Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Rachelle Buchbinder; Kamran Golmohammadi; Renea V Johnston; Richard J Owen; Joanne Homik; Allyson Jones; Sukhvinder S Dhillon; David F Kallmes; Robert GW Lambert

doi:10.1002/14651858.CD006349.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Risk of bias summary: review authors' judgements about the risk of bias of the available evidence presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 1 Pain (0 to 10 point scale).

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Analysis 1.2

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 2 Proportion with improvement in pain of 2.5 units or 30% or more from baseline.

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Analysis 1.3

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 3 Disability (RMDQ).

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Analysis 1.4

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 4 Quality of life (QUALEFFO) [0 to 100].

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Analysis 1.5

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 5 Quality of Life (EQ5D).

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Analysis 1.6

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 6 Treatment success.

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Analysis 2.1

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 1 Pain (0 or 1 to 10 point scale).

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Analysis 2.2

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 2 Disability (RMDQ [0 to 24] or ODI [0 to 100]).

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Analysis 2.3

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 3 Quality of Life (QUALEFFO).

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Analysis 2.4

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 4 Quality of life (EQ5D).

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Analysis 3.1

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 1 Pain (0 to 10 point scale).

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Analysis 3.2

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 2 Disability (ODI).

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Analysis 3.3

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 3 Quality of Life (EQ5D).

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$Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.$

Analysis 4.1

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.

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$Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.$

Analysis 4.2

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.

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Analysis 4.3

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 3 Number of serious other adverse events.

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$Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.$

Analysis 5.1

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.

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$Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.$

Analysis 5.2

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.

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Analysis 6.1

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 1 Pain at 1 to 2 weeks.

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Analysis 6.2

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 2 Pain at 1 month.

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Analysis 6.3

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 3 Disability at 1 to 2 weeks.

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Analysis 6.4

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 4 Disability at 1 month.

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Analysis 6.5

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 5 Quality of life (EQ‐5D) at 1 month.

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Analysis 7.1

Comparison 7 Sensitivity analysis, Outcome 1 Pain at 1 to 2 weeks (0 to 10 scale).

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Analysis 7.2

Comparison 7 Sensitivity analysis, Outcome 2 Pain at 1 month (0 to 10 scale).

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Analysis 7.3

Comparison 7 Sensitivity analysis, Outcome 3 Pain at 3 months (0 to 10 scale).

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Analysis 7.4

Comparison 7 Sensitivity analysis, Outcome 4 Disability at 1 to 2 weeks (RMDQ).

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Analysis 7.5

Comparison 7 Sensitivity analysis, Outcome 5 Disability at 1 month (RMDQ).

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Analysis 7.6

Comparison 7 Sensitivity analysis, Outcome 6 Disability at 3 months (RMDQ).

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Summary of findings for the main comparison. Vertebroplasty for osteoporotic vertebral compression fracture

Vertebroplasty for osteoporotic vertebral compression fracture
Patient or population: people with osteoporotic vertebral compression fracture Settings: hospital Intervention: vertebroplasty versus sham
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Sham¹	Vertebroplasty
Pain Scale from: 0 to 10, 0 is best. Follow‐up: 1 month	The mean pain in the control groups was 5 points	The mean pain in the intervention groups was 0.7 points better (1.5 better to 0.15 worse)		201 (2 studies)	⊕⊕⊕⊝ moderate⁴	Absolute change 7% better (15% better to 1.5% worse); relative change 10% better (21% better to 2% worse); NNTB n/a^2,3
Disability (Roland‐Morris Disability Questionnaire) Scale from: 0 to 23; 0 is best. Follow‐up: 1 month	The mean disability in the control groups was 13.6 points	The mean disability in the intervention groups was 1.09 better (2.94 better to 0.76 worse)		201 (2 studies)	⊕⊕⊕⊝ moderate⁴	Absolute change 4.8% better (12.8% better to 3.3% worse); relative change 6.3% better (17.0% better to 4.4% worse); NNTB n/a^2,3
Disease‐specific quality of Life (QUALEFFO) Scale from: 0 to 100; 0 is best. Follow‐up: 1 month	The mean quality of life (QUALEFFO) in the control groups was 2.4 points	The mean quality of life in the intervention groups was 0.40 points worse (4.58 better to 5.38 worse)		73 (1 study)	⊕⊕⊕⊝ moderate⁴	Absolute change 0.4% worse (5% worse to 5% better); relative change: 0.7% worse (9% worse to 8% better); NNT n/a^2,3
Overall quality of Life (EQ5D) Scale from: 0 to 1; 1 is best. Follow‐up: 1 month	The mean quality of life (EQ‐5D) in the control groups was 0.27 points	The mean quality of life in the intervention groups was 0.05 points better (0.01 worse to 0.11 better)		201 (2 studies)	⊕⊕⊕⊝ moderate⁴	Absolute change 5% better (1% worse to 11% better); relative change: 18% improvement (4% worse to 39% better); NNT n/a^2,3
Participant global assessment of success (People perceived their pain as better) Follow‐up: 1 month	225 per 1000	315 per 1000 (150 to 664)	RR 1.40 (0.67 to 2.95)	78 (1 study)	⊕⊕⊕⊝ moderate⁵	Absolute risk difference 9% more reported success (11% fewer to 29% more); relative change 40% more reported success (33% fewer to 195% more); NNTB n/a²
Incident vertebral fractures Follow‐up: 12 months	138 per 1000	203 per 1000 (54 to 759)	RR 1.47 (0.39 to 5.50)	281 (3 studies)⁶	⊕⊕⊕⊝ moderate⁵	Absolute difference 6% more new fractures with vertebroplasty (2% fewer to 14% more); relative difference 47% more (61% fewer to 450% more); NNTH n/a²
Other serious adverse events Follow‐up: 1 month	28 per 1000	29 per 1000 (6 to 136)	RR 1.01 (0.21 to 4.85)	209 (2 studies)	⊕⊕⊕⊝ moderate⁵	Absolute difference no more events with vertebroplasty (4% fewer to 4% more); relative change 1% more (79% fewer to 385% more); NNTH n/a²
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹For incident vertebral fractures the comparison includes one sham trial and two trials that compared vertebroplasty versus usual care. ² Number needed to treat to benefit (NNTB), or harm (NNTH) not applicable (n/a) when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://www.nntonline.net/visualrx/). NNT for continuous outcomes calculated using Wells Calculator (CMSG editorial office) ³ Relative changes calculated as absolute change (mean difference) divided by mean at baseline in the placebo group from Buchbinder 2009 (values were: 7.1 points on 0 to 10 point VAS pain; 17.3 points on 0 to 23 point Roland‐Morris Disability questionnaire; 0.28 points on EQ‐5D quality of life scale; 59.6 points on the QUALEFFO scale) ⁴ Downgraded due to imprecision: the 95% confidence intervals do not exclude a clinically important change (defined as 1.5 points on 0 to 10 point VAS pain scale; 2 to 3 points on the 0 to 23 point RDQ scale; 0.074 on the 0 to 1 EQ‐5D quality of life scale, and 10 points on the 0 to 100 QUALEFFO scale), or the total number of participants was small, from a single trial only ⁵ Total number of events small ⁶ Pooled both placebo and usual care comparisons in the safety analyses.

Summary of findings for the main comparison. Vertebroplasty for osteoporotic vertebral compression fracture

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Table 1. Study characteristics of unpublished, ongoing and suspended or terminated trials

Trial registration number	Principle Investigator/s and Country	Comparator/s	Main selection criteria	Registration date	Recruitment commenced	Status 24 November 2014	Planned sample size	Final sample size
NCT01482793	Clark W, Bird P Australia	Sham	Age > 60 years Fracture < 6 weeks	28 Nov 2011	Nov 2011	Recruiting (last verified Nov 2011)	120	‐
NCT00749060 ‘OSTEO‐6’	Laredo JD France	Kyphoplasty; Usual care with or without brace	Age ≥ 50 years Fracture < 6 weeks	8 Sept 2008	Dec 2007	Completed June 2012; results unpublished	300	48
NCT00749086 ‘STIC2’	Laredo JD France	Kyphoplasty	Age ≥ 50 years Fracture > 6 weeks	8 Sept 2008	Dec 2007	Completed June 2012; results unpublished	200	97
NCT00635297	Nakstad PH Norway	Vertebroplasty of fractured vertebra +/‐ additional vertebroplasty to adjacent vertebrae	Age > 50 years	5 Mar 2008	Apr 2008	Suspended, reason not stated (last updated 2 Mar 2010)	100	‐
NCT00203554	Sorensen L Denmark	Usual care	Fracture < 6 months	16/09/2005	Mar 2004	Completed Jan 2008; results unpublished	27	27
ISRCTN14442024 (Also N0213112414)	Dolin, S UK	Usual care	Fracture > 4 weeks	12 Sep 2003	Nov 28 2005	Completed (last updated 6 Feb 2014); results unpublished	Not provided	Not provided
chiCTR‐TRC‐14004835	Zhao J, Liu B China	Ordinary vs high viscosity cement	Includes osteoporotic fractures, haemangiomas and metastatic disease	23 Jun 2014	Planned 1 Jan 2015	Not yet recruiting	100	‐
NCT01677806	Sun G China	Usual care	Age ≥ 50 years Fracture < 6 weeks	23 Aug 2012	Oct 2012	Recruiting (last updated 7 Aug 2014)	114	‐
NCT01537770 (also EUCTR2010‐024050‐10‐DK ‘VOPE’	Hansen EJ, Andersen MO, Rousing R, Tropp H Denmark	Lidocaine	Age > 50 years	6 Jan 2011	Feb 2012	No longer recruiting (last updated 21 Oct 2014)	80	‐
NTR3282	Nieuwenhuijse MJ Netherlands	Low vs high viscosity cement	‐	14 Feb 2012	Jan 2011	Recruiting (last updated 21 July 2014)	86	‐
NCT01200277 ‘VERTOS IV’	van Rooij HJ, De Vries J, Lohle PN Netherlands	Sham	Age ≥ 50 years Fracture ≤ 6 weeks	7 Sept 2010	Jan 2011	Completed (last updated 19 Nov 2014)	80	‐
NCT00279877	Evans A USA	Kyphoplasty		18 Jan 2006	May 2005	Completed May 2011; results unpublished	112	Not provided
Registration details not found.	Longo UG Italy	3 weeks bed rest, rigid hyperextension corset, followed by 2‐3 months in a Cheneau brace (called ‘double‐blind)	Age ≥ 50 years	Trial registration not found	Unknown	Unknown (protocol published)	200	‐
NCT01963039 ‘VERTOS V’	Carli D Netherlands	Sham	Age ≥ 50 years Fracture ≥ 12 weeks	28 Aug 2013	May 2013	Recruiting (last updated Oct 2013)(protocol published)	94	‐
Registration details not found. Results published as conference abstract*	Hao, D, Guo, H, Wang, B, Wang X China	Facet joint block	Age ≥55 years Fracture ≤ 8 weeks	Trial registration not found	Jan 2009	Recruitment completed Jan 2013	Not stated	206 (100 in VP; 106 in facet block group)
* Abstract reported that analysis favoured vertebroplasty at 1 day and 1 week for pain and disability measured by RMDQ and ODI but no between‐group differences at 1, 3, 6, 12 months for pain, RMDQ, ODI and SF‐36 function and SF‐36 physical and mental component scores. After 12 months follow‐up, there were 13 new fractures in the percutaneous vertebroplasty group and 11 new fractures in the facet joint block group. Abstract did not report method of randomisation, whether or not treatment allocation was concealed and whether or not participants and investigators were blinded to treatment allocation.

Table 1. Study characteristics of unpublished, ongoing and suspended or terminated trials

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Table 2. Baseline demographic and clinical characteristics of the trial participants

Study	Country	Treatment Groups	Mean age, yrs	Mean symptom duration	Mean (SD) baseline pain (0‐10 scale^$)	Mean (SD) baseline RMDQ⁺ (0‐24 scale^†)	Mean (SD) baseline QUALEFFO (0‐100 scale)	Procedures performed by	Mean (range) volume cement injected (mL)	Follow‐up
Blasco 2012	Spain	Vertebroplasty	71.3	140.3 days	7.2 (0.3)	‐	65.2 (2.2)	Interventional radiologists	Not specified	2 weeks, 2, 6, 12 months
		Usual care	71.3	143.1 days	6.3 (0.4)	‐	59.2 (2.2)
Buchbinder 2009	Australia	Vertebroplasty	74.2	9 weeks^	7.4 (2.1)	17.3 (2.8)	56.9 (13.4)	Interventional radiologists	2.8 (1.2 ‐ 5.5)	1 week, 1, 3, 6, 12, 24 months
		Placebo	78.9	9.5 weeks^	7.1 (2.3)	17.3 (2.9)	59.6 (17.1)
Chen 2014	China	Vertebroplasty	64.6	31 weeks	6.5 (0.9)^&	18.6 (1.8)^#&	‐	Orthopaedic surgeons	3.6 (3 ‐ 6)	1 day, 1 week, 1, 3, 6, 12 months
		Usual care and brace	66.5	29.5 weeks	6.4 (0.9)^&	16.7 (1.3)^#&	‐
Dohm 2014	USA and Canada	Vertebroplasty	75.7	‐¤	˜7.6^µ	‐	‐	Interventional radiologists and neuroradiologists, orthopaedic surgeons, neuroradiologists	4.0 (3.0 to 6.0)^¢	7 days, 1, 3, 12 and 24 months
		Balloon kyphoplasty	75.5	‐¤	˜7.6^µ	‐		Not stated	4.6 (3.4 to 6.0)^¢
Endres 2012	Germany	Vertebroplasty	71.3	‐^§	7.8 (0.9)	‐	‐	Orthopaedic surgeon	3.1 (2 – 4)	Immediately, mean 5.8 months (range: 4 to 7)
		Balloon kyphoplasty	63.3	‐^§	9.0 (0.7)	‐	‐	Orthopaedic surgeon	3.9 (3 – 5)
		Shield kyphoplasty	67.1	‐^§	8.8 (1.5)	‐	‐	Orthopaedic surgeon	4.6 (3 – 6)
Farrokhi 2011	Iran	Vertebroplasty	72	27 weeks	8.4 (1.6)	‐	‐	Neurosurgeons	3.5 (1 ‐ 5.5)	1 week, 2, 6, 12, 24, 36 months
		Usual care	74	30 weeks	7.2 (1.7)	‐	‐
Kallmes 2009	US, UK, Australia	Vertebroplasty	73.4	16 weeks	6.9 (2.0)	16.6 (3.8)	‐	Interventional radiologists	2.8 (1 ‐ 5.5)*	3 days, 2 weeks, 1 month
		Placebo	73.3	20 weeks	7.2 (2.0)	17.5 (4.1)	‐
Klazen 2010	Netherlands, Belgium	Vertebroplasty	75.2	29.3 days	7.8 (1.5)	18.6 (3.6)^#	58.7 (13.5)	Interventional radiologists	4.1 (1 ‐ 9)	1 day, 1 week, 1, 3, 6, 12 months
		Usual care	75.4	26.8 days	7.5 (1.6)	17.2 (4.2)^#	54.7 (14.4)
Liu 2010	Taiwan	Vertebroplasty	74.3	15.8 days	7.9 (0.7)	‐	‐	Not stated	4.9 (0.7)	3 days, 6 months
		Balloon kyphoplasty	72.3	17.0 days	8.0 (0.8)	‐	‐	Not stated	5.6 (0.6)
Rousing 2009	Denmark	Vertebroplasty	80	8.4 days	7.5 (2.0)	‐	‐	Orthopedic surgeons	Not specified	3 months
		Usual care and brace	80	6.7 days	8.8 (1.2)	‐	‐
Vogl 2013	Germany and USA	Vertebroplasty	74	‐^¥	8.5 (1.2)	‐	‐	Not stated	4.0 (1.1)	1 day, 3, 12 months
		Shield kyphoplasty	80	‐^¥	8.3 (1.1)	‐	‐	Not stated	3.8 (0.7)
Voormolen 2007	Netherlands	Vertebroplasty	72	85 days	7.1 (5 ‐ 9)⁺	15.7 (8‐24)	60.0 (37 to 86)⁺	Interventional radiologists	3.2 (1.0 ‐ 5.0)	2 weeks
		Usual care	74	76 days	7.6 (5‐10)	17.8 (8‐22)	60.7 (38 to 86)
^$1‐10 point scale used by Farrokhi 2011; ⁺RMDQ: Roland Morris Disability Questionnaire; ^†modified RMDQ (0‐23 scale) used by Buchbinder 2009 and Kallmes 2009; ^ median duration of symptoms; ^¤Not reported but symptom duration 6 months or less; ^µMean symptom duration reported graphically only; ^¢Median and interquartile range;^§Not reported but symptom duration 6 weeks or less; ^&Data only included for the 42/46 in VP group and 43/50 in the usual care group who completed 12‐month follow‐up in groups assigned to at baseline; ^#Disability significantly higher in the vertebroplasty group; *from n = 20 treated at Mayo (personal communication); ^¥Not reported but at least 6 weeks of conservative treatment; ⁺Only range provided.

Table 2. Baseline demographic and clinical characteristics of the trial participants

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Comparison 1. Efficacy: Vertebroplasty versus placebo (sham)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (0 to 10 point scale) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 1 to 2 weeks	2	205	Mean Difference (IV, Random, 95% CI)	0.12 [‐0.65, 0.88]
1.2 1 month	2	201	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.48, 0.15]
1.3 3 months	1	73	Mean Difference (IV, Random, 95% CI)	‐0.70 [‐2.12, 0.72]
1.4 6 months	1	71	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐1.84, 1.24]
1.5 12 months	1	67	Mean Difference (IV, Random, 95% CI)	‐0.5 [‐1.82, 0.82]
1.6 24 months	1	57	Mean Difference (IV, Random, 95% CI)	‐1.1 [‐2.68, 0.48]
2 Proportion with improvement in pain of 2.5 units or 30% or more from baseline Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Pain improved at 1 week	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.58, 1.90]
2.2 Pain improved at 1 month	2	206	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.97, 1.66]
2.3 Pain improved at 3 months	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.89, 2.66]
2.4 Pain improved at 6 months	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.80, 2.22]
2.5 Pain improved at 12 months	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.67, 2.20]
2.6 Pain improved as 24 months	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.84, 2.42]
3 Disability (RMDQ) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 1 to 2 weeks	2	190	Mean Difference (IV, Random, 95% CI)	0.82 [‐1.13, 2.78]
3.2 1 month	2	187	Mean Difference (IV, Random, 95% CI)	‐1.09 [‐2.94, 0.76]
3.3 3 months	1	59	Mean Difference (IV, Random, 95% CI)	1.60 [‐1.66, 4.86]
3.4 6 months	1	59	Mean Difference (IV, Random, 95% CI)	‐0.40 [‐3.36, 2.56]
3.5 12 months	1	48	Mean Difference (IV, Random, 95% CI)	0.60 [‐3.02, 4.22]
3.6 24 months	1	43	Mean Difference (IV, Random, 95% CI)	0.10 [‐3.67, 3.87]
4 Quality of life (QUALEFFO) [0 to 100] Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4.1 1 week	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 1 month	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 3 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.4 6 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.5 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.6 24 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
5 Quality of Life (EQ5D) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 1 to 2 weeks	1	59	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.15, 0.15]
5.2 1 month	2	187	Mean Difference (IV, Random, 95% CI)	0.05 [‐0.01, 0.11]
5.3 3 months	1	59	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.18, 0.18]
5.4 6 months	1	59	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.20, 0.20]
5.5 12 months	1	47	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.23, 0.23]
5.6 24 months	1	44	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.24, 0.24]
6 Treatment success Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

6.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.2 1 month	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.3 3 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.4 6 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.5 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.6 24 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Efficacy: Vertebroplasty versus placebo (sham)

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Comparison 2. Efficacy: Vertebroplasty versus usual care (open label)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (0 or 1 to 10 point scale) Show forest plot	6		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 1 to 2 weeks	5	520	Std. Mean Difference (IV, Random, 95% CI)	‐1.07 [‐2.01, ‐0.14]
1.2 1 month	2	277	Std. Mean Difference (IV, Random, 95% CI)	‐1.62 [‐3.01, ‐0.24]
1.3 2 to 3 months	5	520	Std. Mean Difference (IV, Random, 95% CI)	‐0.90 [‐1.59, ‐0.21]
1.4 6 months	4	466	Std. Mean Difference (IV, Random, 95% CI)	‐0.88 [‐1.71, ‐0.04]
1.5 12 months	5	505	Std. Mean Difference (IV, Random, 95% CI)	‐0.83 [‐1.55, ‐0.11]
1.6 24 months	1	77	Std. Mean Difference (IV, Random, 95% CI)	‐0.45 [‐0.90, 0.01]
2 Disability (RMDQ [0 to 24] or ODI [0 to 100]) Show forest plot	5		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 1 to 2 weeks	4	387	Std. Mean Difference (IV, Random, 95% CI)	‐2.04 [‐3.57, ‐0.50]
2.2 1 month	2	271	Std. Mean Difference (IV, Random, 95% CI)	‐0.94 [‐2.30, 0.43]
2.3 3 months	4	396	Std. Mean Difference (IV, Random, 95% CI)	‐1.90 [‐3.76, ‐0.04]
2.4 6 months	3	354	Std. Mean Difference (IV, Random, 95% CI)	‐1.69 [‐3.55, 0.17]
2.5 12 months	4	389	Std. Mean Difference (IV, Random, 95% CI)	‐1.26 [‐2.61, 0.08]
2.6 24 months	1	77	Std. Mean Difference (IV, Random, 95% CI)	‐5.65 [‐6.67, ‐4.63]
3 Quality of Life (QUALEFFO) Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 1 to 2 weeks	3	341	Mean Difference (IV, Random, 95% CI)	‐4.01 [‐11.77, 3.75]
3.2 1 month	1	182	Mean Difference (IV, Random, 95% CI)	‐4.21 [‐8.86, 0.44]
3.3 2 to 3 months	2	308	Mean Difference (IV, Random, 95% CI)	‐1.61 [‐8.10, 4.88]
3.4 6 months	2	308	Mean Difference (IV, Random, 95% CI)	‐0.83 [‐6.48, 4.83]
3.5 12 months	2	308	Mean Difference (IV, Random, 95% CI)	‐0.46 [‐5.09, 4.18]
4 Quality of life (EQ5D) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 1 to 2 weeks	1	183	Mean Difference (IV, Random, 95% CI)	0.08 [0.00, 0.15]
4.2 1 month	1	183	Mean Difference (IV, Random, 95% CI)	0.09 [0.01, 0.16]
4.3 3 months	2	215	Mean Difference (IV, Random, 95% CI)	0.10 [0.00, 0.20]
4.4 6 months	1	183	Mean Difference (IV, Random, 95% CI)	0.07 [‐0.02, 0.15]
4.5 12 months	2	215	Mean Difference (IV, Random, 95% CI)	0.07 [‐0.00, 0.14]

Comparison 2. Efficacy: Vertebroplasty versus usual care (open label)

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Comparison 3. Efficacy: Vertebroplasty versus kyphoplasty (balloon)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (0 to 10 point scale) Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 1 to 2 weeks	1	364	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.75, 0.35]
1.2 1 month	1	342	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.69, 0.49]
1.3 3 months	1	314	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.74, 0.54]
1.4 6 months	2	141	Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.41, 0.24]
1.5 12 months	1	275	Mean Difference (IV, Random, 95% CI)	0.30 [‐0.40, 1.00]
1.6 24 months	1	220	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.72, 0.92]
2 Disability (ODI) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

2.1 1 month	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 3 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.4 24 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3 Quality of Life (EQ5D) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3.1 1 month	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 3 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 24 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Efficacy: Vertebroplasty versus kyphoplasty (balloon)

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Comparison 4. Safety: Vertebroplasty versus placebo (sham) or usual care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 New clinical vertebral fractures Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 12 months	3	281	Risk Ratio (M‐H, Random, 95% CI)	1.47 [0.39, 5.50]
1.2 24 months	2	134	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.09, 3.38]
2 New radiographic vertebral fractures Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 12 months	4	397	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.55, 3.74]
2.2 24 months	1	43	Risk Ratio (M‐H, Random, 95% CI)	1.48 [0.90, 2.44]
3 Number of serious other adverse events Show forest plot	2	209	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.21, 4.85]

Comparison 4. Safety: Vertebroplasty versus placebo (sham) or usual care

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Comparison 5. Safety: Vertebroplasty versus kyphoplasty

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 New clinical vertebral fractures Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 24 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 New radiographic vertebral fractures Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 24 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. Safety: Vertebroplasty versus kyphoplasty

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Comparison 6. Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 1 to 2 weeks Show forest plot	2	201	Mean Difference (IV, Random, 95% CI)	0.19 [‐0.58, 0.95]

1.1 Duration pain ≤ 6 weeks	2	44	Mean Difference (IV, Random, 95% CI)	0.64 [‐0.97, 2.26]
1.2 Duration pain > 6 weeks	2	157	Mean Difference (IV, Random, 95% CI)	0.05 [‐0.81, 0.92]
2 Pain at 1 month Show forest plot	2	201	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.44, 0.13]

2.1 Duration pain ≤ 6 weeks	2	44	Mean Difference (IV, Random, 95% CI)	0.04 [‐1.80, 1.87]
2.2 Duration pain > 6 weeks	2	157	Mean Difference (IV, Random, 95% CI)	‐0.81 [‐1.68, 0.05]
3 Disability at 1 to 2 weeks Show forest plot	2	182	Mean Difference (IV, Random, 95% CI)	0.64 [‐0.88, 2.15]

3.1 Duration pain ≤ 6 weeks	2	41	Mean Difference (IV, Random, 95% CI)	0.20 [‐3.33, 3.72]
3.2 Duration pain > 6 weeks	2	141	Mean Difference (IV, Random, 95% CI)	0.74 [‐0.94, 2.42]
4 Disability at 1 month Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 Duration pain ≤ 6 weeks	2	41	Mean Difference (IV, Random, 95% CI)	‐0.43 [‐4.02, 3.16]
4.2 Duration pain > 6 weeks	2	142	Mean Difference (IV, Random, 95% CI)	‐0.83 [‐2.87, 1.21]
5 Quality of life (EQ‐5D) at 1 month Show forest plot	2	183	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.01, 0.10]

5.1 Duration pain ≤ 6 weeks	2	41	Mean Difference (IV, Random, 95% CI)	0.05 [‐0.07, 0.16]
5.2 Duration pain > 6 weeks	2	142	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.02, 0.10]

Comparison 6. Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks

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Comparison 7. Sensitivity analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 1 to 2 weeks (0 to 10 scale) Show forest plot	7	725	Std. Mean Difference (IV, Random, 95% CI)	‐0.43 [‐0.91, 0.06]

1.1 Sham (placebo) control	2	205	Std. Mean Difference (IV, Random, 95% CI)	0.04 [‐0.24, 0.31]
1.2 Usual care (open label) control	5	520	Std. Mean Difference (IV, Random, 95% CI)	‐0.64 [‐1.27, ‐0.00]
2 Pain at 1 month (0 to 10 scale) Show forest plot	4	478	Std. Mean Difference (IV, Random, 95% CI)	‐0.91 [‐1.71, ‐0.12]

2.1 Sham (placebo) control	2	201	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.50, 0.06]
2.2 Usual care (open label) control	2	277	Std. Mean Difference (IV, Random, 95% CI)	‐1.62 [‐3.01, ‐0.24]
3 Pain at 3 months (0 to 10 scale) Show forest plot	6	593	Std. Mean Difference (IV, Random, 95% CI)	‐0.79 [‐1.38, ‐0.20]

3.1 Sham (placebo) control	1	73	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.68, 0.24]
3.2 Usual care (open label) control	5	520	Std. Mean Difference (IV, Random, 95% CI)	‐0.90 [‐1.59, ‐0.21]
4 Disability at 1 to 2 weeks (RMDQ) Show forest plot	5	510	Mean Difference (IV, Random, 95% CI)	‐1.60 [‐3.32, 0.12]

4.1 Sham (placebo) control	2	205	Mean Difference (IV, Random, 95% CI)	0.94 [‐1.08, 2.96]
4.2 Usual care (open label) control	3	305	Mean Difference (IV, Random, 95% CI)	‐2.82 [‐4.12, ‐1.53]
5 Disability at 1 month (RMDQ) Show forest plot	4	472	Mean Difference (IV, Random, 95% CI)	‐1.26 [‐2.51, ‐0.00]

5.1 Sham (placebo) control	2	201	Mean Difference (IV, Random, 95% CI)	0.12 [‐2.40, 2.64]
5.2 Usual care (open label) control	2	271	Mean Difference (IV, Random, 95% CI)	‐2.05 [‐2.56, ‐1.54]
6 Disability at 3 months (RMDQ) Show forest plot	3	344	Mean Difference (IV, Random, 95% CI)	‐1.64 [‐3.52, 0.24]

6.1 Sham (placebo) control	1	73	Mean Difference (IV, Random, 95% CI)	1.60 [‐1.31, 4.51]
6.2 Usual care (open label) control	2	271	Mean Difference (IV, Random, 95% CI)	‐2.59 [‐3.04, ‐2.15]

Comparison 7. Sensitivity analysis

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