Bisphosphonates for osteoporosis in people with cystic fibrosis

Tomas C Jeffery; Anne B Chang; Louise S Conwell

doi:10.1002/14651858.CD002010.pub5

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Figure 1

Selection process for this update.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

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

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$Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1a Number of participants with any fracture.$

Figure 4

Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1a Number of participants with any fracture.

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$Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1b i. Number of participants with non‐vertebral fractures.$

Figure 5

Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1b i. Number of participants with non‐vertebral fractures.

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$Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1b ii. Number of participants with vertebral fractures.$

Figure 6

Forest plot of comparison between bisphosphonates versus control (without lung transplantation), Outcome 1b ii. Number of participants with vertebral fractures.

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$Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 1: Total fractures$

Analysis 1.1

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 1: Total fractures

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$Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 2: Non‐vertebral fractures$

Analysis 1.2

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 2: Non‐vertebral fractures

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$Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 3: Vertebral fractures$

Analysis 1.3

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 3: Vertebral fractures

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Analysis 1.4

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 4: % change in BMD, lumbar spine [DXA]

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Analysis 1.5

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 5: % change in BMD, lumbar spine [DXA] (end of trial data only)

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Analysis 1.6

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 6: % change in BMD, total hip/femur [DXA]

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Analysis 1.7

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 7: % change in BMD, total hip/femur [DXA] (end of trial data only)

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Analysis 1.8

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 8: % change in BMD, distal radius [SXA]

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Analysis 1.9

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 9: % change in BMD, distal radius [SXA] (end of trial data only)

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Analysis 1.10

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 10: % change in BMD, ultra distal radius [SXA]

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Analysis 1.11

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 11: QoL

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Analysis 1.12

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 12: Bone pain

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Analysis 1.13

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 13: Fever

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Analysis 1.14

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 14: Withdrawals due to adverse events

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Analysis 1.15

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 15: Withdrawals (total)

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Analysis 1.16

Comparison 1: Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over), Outcome 16: Survival

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$Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 1: Total fractures$

Analysis 2.1

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 1: Total fractures

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$Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 2: Non‐vertebral fractures$

Analysis 2.2

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 2: Non‐vertebral fractures

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$Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 3: Vertebral fractures$

Analysis 2.3

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 3: Vertebral fractures

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Analysis 2.4

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 4: % change in BMD, lumbar spine, DXA

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Analysis 2.5

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 5: Bone or muscle pain

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Analysis 2.6

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 6: Fever

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Analysis 2.7

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 7: Gastrointestinal adverse events

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Analysis 2.8

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 8: Headache

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Analysis 2.9

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 9: Any adverse event

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Analysis 2.10

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 10: Withdrawals, due to adverse events

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Analysis 2.11

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 11: Withdrawals, total

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Analysis 2.12

Comparison 2: Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age, Outcome 12: Survival

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Analysis 3.1

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 1: Total Fractures

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$Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 2: Non‐vertebral fractures$

Analysis 3.2

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 2: Non‐vertebral fractures

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$Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 3: Vertebral fractures$

Analysis 3.3

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 3: Vertebral fractures

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Analysis 3.4

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 4: % change in BMD, lumbar spine, DXA

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Analysis 3.5

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 5: % change in BMD, femur, DXA

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Analysis 3.6

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 6: Bone pain

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Analysis 3.7

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 7: Withdrawals, due to adverse events

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Analysis 3.8

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 8: Withdrawals, total

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Analysis 3.9

Comparison 3: Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over), Outcome 9: Survival

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Summary of findings 1. Bisphosphonates compared with control for osteoporosis in people with cystic fibrosis who have not had a lung transplant

Patient or population: adults with cystic fibrosis who have not had a lung transplant

Settings: outpatients
Intervention: bisphosphonates^a

Comparison: placebo or no bisphosphonates^b

Outcomes

Illustrative comparative risks^* (95% CI)

Relative

effect (95% CI)

Number of

participants

(studies)

Certainty of

the evidence

(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Bisphosphonates

New vertebral fractures

Follow‐up: 12 months

42 per 1000

9 per 1000

(1 to 88)

OR 0.22

(0.02 to 2.09)

142

(5)

⊕⊝⊝⊝

very low^c,d

New non‐vertebral fractures

Follow‐up: 12 months

21 per 1000

44 per 1000

(4 to 532)

OR 2.11

(0.18 to 25.35)

(4)

⊕⊝⊝⊝

very low^d,e

BMD: % change in BMD at the lumbar spine

Follow‐up: 12 months

The mean % change in BMD (lumbar spine) ranged across control groups

from ‐1.8% to 0.7%

The mean % change in BMD in the intervention groups was 6.31% higher (5.39% higher to 7.22% higher)

171

(6)

⊕⊕⊝⊝

low^f

BMD: % change in BMD at the hip or femur

Follow‐up: 12 months

The mean % change in BMD

(hip or femur) ranged across control groups from ‐2.8% to ‐0.7%

The mean % change in BMD in the intervention groups was 4.41% higher (3.44% higher to 5.37% higher)

155

(5)

⊕⊕⊝⊝

low^f

QoL: change in physical and mental component scores (SF36v2)

Follow‐up: 12 months

The change in mean (SD) SF36 physical score was ‐3.69 (8.33) in the control group

The mean change in SF36 physical score in the intervention group was 2.51 higher (1.38 lower to 6.40 higher) than in the control group

(1)

⊕⊕⊝⊝

low^d,g

The results for the physical and mental components are heterogeneous

The change in mean (SD) SF36 mental score was 3.26 (12.27) in the control group

The mean change in SF36 mental score in the intervention group was 5.93 lower (11.73 lower to 0.13 higher) than in the control group

Adverse events: bone pain (all routes of bisphosphonate administration)

Follow‐up: 12 months

38 per 1000

323 per 1000

(122 to 857)

OR 8.49 (3.20 to 22.56)

206

(7)

⊕⊕⊕⊝

moderate^h

Bone pain

Separating by route of administration did not change the results; both routes favoured control.

Oral bisphosphonates: MD 4.98 (1.24 to 20.09) and IV bisphosphonates: MD 14.17 (3.64 to 55.17)

Fever

Oral route: 2 trials of oral alendronate reported that none of the participants in either group experienced fever

IV route: 3 trials showed that bisphosphonates were associated with a higher occurrence of fever OR 12.64 (2.31 to 69.11)

GI adverse effects

Only measured in the oral bisphosphonates trials. At 12 months, 1 trial reported 3 occurrences of diarrhoea (1 in the bisphosphonate group and 2 in the placebo group) (Aris 2004)

1 trial reported no GI adverse effects in either group (Bianchi 2013)

1 trial reported 10 GI adverse events in the bisphosphonates group compared to 7 in the control group (Papaioannou 2008)

^*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

BMD: bone mineral density; CI: confidence interval; GI: gastrointestinal; IV: intravenous; MD: mean difference; NA: not applicable; OR: odds ratio; QoL: quality of life; SD: standard deviation; SF36v2: medical outcomes study 36‐item short form.

GRADE Working Group grades of evidence

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.

Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.

Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

^aTrials used different types and formulations of bisphosphonates: IV zoledronate (Boyle 2005; Chapman 2009); IV pamidronate (Haworth 2001); oral alendronate (Aris 2004; Bianchi 2013; Krasovsky 2010; Papaioannou 2008); oral risedronate (Haworth 2011).
^bTrials used different comparators: placebo (Aris 2004; Bianchi 2013; Boyle 2005; Chapman 2009; Haworth 2011; Papaioannou 2008); no bisphosphonate (cholecalciferol/calcium) (Krasovsky 2010), no bisphosphonate (oral calcium) (Haworth 2001).
^cDowngraded twice due to risk of bias across some domains in 5/6 included trials. There were particular concerns around the process of randomisation and allocation concealment in 3 trials and lack of blinding in 1 trial.
^dDowngraded once due to imprecision caused by low event rates and small sample size.
^eDowngraded twice for risk of bias across some domains of all trials included for this outcome. There were particular concerns around randomisation and allocation concealment.
^fDowngraded twice due to risk of bias across 1 or more domains in most of the trials included for this outcome. There were particular concerns around randomisation, allocation concealment, and blinding.
^gDowngraded once due to heterogeneity within the results.
^hDowngraded once due to risk of bias within the included trials; 3/7 trials were at low risk of bias across most domains and particularly randomisation and allocation concealment therefore we did not feel it necessary to downgrade twice.

Summary of findings 1. Bisphosphonates compared with control for osteoporosis in people with cystic fibrosis who have not had a lung transplant

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Summary of findings 2. Bisphosphonates compared with placebo for osteoporosis in children with cystic fibrosis who have not had a lung transplant

Patient or population: children with cystic fibrosis who have not had a lung transplant Settings: outpatients Intervention: oral alendronate plus oral calcifediol and RDA dietary calcium Comparison: oral placebo plus oral calcifediol and RDA dietary calcium
Outcomes	*Illustrative comparative risks^ (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Bisphosphonates
New vertebral fractures Follow‐up: 12 months	54 per 1000	17 per 1000 (2 to 169)	OR 0.32 (0.03 to 3.13)	113 (1)	⊕⊕⊝⊝ low^a
New non‐vertebral fractures Follow‐up: 12 months	36 per 1000	7 per 1000 (1 to 145)	OR 0.19 (0.01 to 4.04)	113 (1)	⊕⊕⊝⊝ low^a
BMD: % change in BMD at the lumbar spine Follow‐up: 12 months	The % change in BMD at the lumbar spine was higher in the treatment group than the control group, MD 14.50 (95% CI 12.91 to 16.09)		NA	113 (1)	⊕⊕⊝⊝ low^a
BMD: % change in BMD at the hip or femur	This outcome was not reported
QoL	This outcome was not reported
Adverse events Follow‐up: 12 months	There was no difference in bone or muscle pain, OR 3.00 (95% CI 0.12 to 75.22); fever, OR 3.00 (95% CI 0.12 to 75.22); or GI adverse events OR 0.67 (95% CI 0.20 to 2.26)		NA	113 (1)	⊕⊕⊝⊝ low^a
^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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMD: bone mineral density; CI: confidence interval; GI: gastrointestinal; MD: mean difference; NA: not applicable; OR: odds ratio; QoL: quality of life; RDA: recommended daily allowance.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded twice due to imprecision cause by small participant numbers and low event rates.

Summary of findings 2. Bisphosphonates compared with placebo for osteoporosis in children with cystic fibrosis who have not had a lung transplant

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Summary of findings 3. Bisphosphonates compared with no bisphosphonates for osteoporosis in people with cystic fibrosis who have had a lung transplant

Patient or population: adults with cystic fibrosis who have had a lung transplant Settings: outpatients Intervention: bisphosphonates (IV pamidronate plus oral vitamin D and oral calcium) Comparison: oral vitamin D and oral calcium
Outcomes	*Illustrative comparative risks^ (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Bisphosphonates
New vertebral fractures Follow‐up: 12 months	This outcome was not reported at 12 months ‐ see comments					1 study reported results at 24 months (Aris 2000) and found no difference in the number of participants with a vertebral fracture, OR 3.92 (95% CI 0.36 to 42.20)
New non‐vertebral fractures Follow‐up: 12 months	This outcome was not reported at 12 months ‐ see comments					1 study reported results at 24 months (Aris 2000) and found no difference in the number of participants with a non‐vertebral fracture, OR 0.46 (95% CI 0.09 to 2.27)
BMD: % change in BMD at the lumbar spine Follow‐up: 12 months	This outcome was not reported at 12 months ‐ see comments					1 study reported results at 24 months (Aris 2000) and found the % change in BMD was higher in the treatment group than the control group MD 6.20 (95% CI 4.28 to 8.12)
BMD: % change in BMD at the hip or femur Follow‐up: 12 months	This outcome was not reported at 12 months ‐ see comments					1 study reported results at 24 months (Aris 2000) and found the % change in BMD was higher in the treatment group than the control group, MD 7.90 (95% CI 5.78 to 10.02).
QoL	This outcome was not reported at any time point
Adverse events Follow‐up: 12 months	This outcome was not reported at 12 months ‐ see comment					1 study reported results at 24 months (Aris 2000) and found none of the participants in either group experienced bone pain or fever
^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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMD: bone mineral density; CI: confidence interval; IV: intravenous; MD: mean difference; OR: odds ratio; QoL: quality of life.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

Summary of findings 3. Bisphosphonates compared with no bisphosphonates for osteoporosis in people with cystic fibrosis who have had a lung transplant

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Comparison 1. Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Total fractures Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1.1 12 months	5	142	Odds Ratio (M‐H, Fixed, 95% CI)	0.57 [0.13, 2.50]
1.1.2 24 months	2	44	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.2 Non‐vertebral fractures Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.2.1 12 months	4	95	Odds Ratio (M‐H, Fixed, 95% CI)	2.11 [0.18, 25.35]
1.2.2 24 months	2	44	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.3 Vertebral fractures Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.3.1 12 months	5	142	Odds Ratio (M‐H, Fixed, 95% CI)	0.22 [0.02, 2.09]
1.3.2 24 months	2	44	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.4 % change in BMD, lumbar spine [DXA] Show forest plot	8		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.4.1 6 months	4	101	Mean Difference (IV, Fixed, 95% CI)	4.61 [3.90, 5.32]
1.4.2 12 months	6	171	Mean Difference (IV, Fixed, 95% CI)	6.31 [5.39, 7.22]
1.4.3 24 months	2	43	Mean Difference (IV, Fixed, 95% CI)	5.49 [4.38, 6.60]
1.5 % change in BMD, lumbar spine [DXA] (end of trial data only) Show forest plot	8		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.5.1 End of trial	8	199	Mean Difference (IV, Fixed, 95% CI)	5.95 [5.17, 6.73]
1.6 % change in BMD, total hip/femur [DXA] Show forest plot	6		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.6.1 6 months	3	96	Mean Difference (IV, Fixed, 95% CI)	3.58 [2.75, 4.40]
1.6.2 12 months	5	155	Mean Difference (IV, Fixed, 95% CI)	4.41 [3.44, 5.37]
1.6.3 24 months	2	42	Mean Difference (IV, Fixed, 95% CI)	6.49 [5.32, 7.66]
1.7 % change in BMD, total hip/femur [DXA] (end of trial data only) Show forest plot	6		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.7.1 End of trial	6	178	Mean Difference (IV, Fixed, 95% CI)	4.89 [4.06, 5.72]
1.8 % change in BMD, distal radius [SXA] Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.8.1 6 months	2	48	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.73, 0.78]
1.8.2 12 months	1	18	Mean Difference (IV, Fixed, 95% CI)	0.32 [‐0.30, 0.94]
1.8.3 24 months	1	14	Mean Difference (IV, Fixed, 95% CI)	1.50 [0.41, 2.59]
1.9 % change in BMD, distal radius [SXA] (end of trial data only) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.9.1 End of study	2	42	Mean Difference (IV, Fixed, 95% CI)	0.74 [‐0.21, 1.70]
1.10 % change in BMD, ultra distal radius [SXA] Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.10.1 6 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.11 QoL Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.11.1 Physical component	1	47	Mean Difference (IV, Fixed, 95% CI)	2.51 [‐1.38, 6.40]
1.11.2 Mental component	1	47	Mean Difference (IV, Fixed, 95% CI)	‐5.93 [‐11.73, ‐0.13]
1.12 Bone pain Show forest plot	7		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.12.1 All routes of bisphosphonate administration	7	206	Odds Ratio (M‐H, Fixed, 95% CI)	8.49 [3.20, 22.56]
1.12.2 Oral bisphosphonates	4	146	Odds Ratio (M‐H, Fixed, 95% CI)	4.98 [1.24, 20.09]
1.12.3 Intravenous bisphosphonates	3	60	Odds Ratio (M‐H, Fixed, 95% CI)	14.17 [3.64, 55.17]
1.13 Fever Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.13.1 All routes of bisphosphonate administration	5	118	Odds Ratio (M‐H, Fixed, 95% CI)	12.64 [2.31, 69.11]
1.13.2 Oral bisphosphonates	2	63	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.13.3 Intravenous bisphosphonates	3	55	Odds Ratio (M‐H, Fixed, 95% CI)	12.64 [2.31, 69.11]
1.14 Withdrawals due to adverse events Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.14.1 6 months	2	53	Odds Ratio (M‐H, Fixed, 95% CI)	3.95 [0.14, 108.09]
1.14.2 12 months	5	177	Odds Ratio (M‐H, Fixed, 95% CI)	4.07 [1.11, 14.90]
1.14.3 24 months	2	58	Odds Ratio (M‐H, Fixed, 95% CI)	16.34 [1.98, 134.89]
1.15 Withdrawals (total) Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.15.1 6 months	2	53	Odds Ratio (M‐H, Fixed, 95% CI)	1.77 [0.27, 11.60]
1.15.2 12 months	5	177	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.45, 2.28]
1.15.3 24 months	2	58	Odds Ratio (M‐H, Fixed, 95% CI)	0.95 [0.34, 2.69]
1.16 Survival Show forest plot	7		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.16.1 6 months	2	36	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.05, 16.39]
1.16.2 12 months	4	155	Odds Ratio (M‐H, Fixed, 95% CI)	2.98 [0.30, 29.84]
1.16.3 24 months	2	58	Odds Ratio (M‐H, Fixed, 95% CI)	4.27 [0.43, 42.63]

Comparison 1. Bisphosphonates versus control (without lung transplantation) ‐ adults (18 years and over)

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Comparison 2. Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Total fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.2 Non‐vertebral fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.2.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.3 Vertebral fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.3.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.4 % change in BMD, lumbar spine, DXA Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.4.1 12 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2.5 Bone or muscle pain Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.5.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.6 Fever Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.6.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.7 Gastrointestinal adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.7.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.8 Headache Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.8.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.9 Any adverse event Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.9.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.10 Withdrawals, due to adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.10.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.11 Withdrawals, total Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.11.1 12 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.12 Survival Show forest plot	1	113	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable

2.12.1 12 months	1	113	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 2. Bisphosphonates versus control (without lung transplantation) ‐ children up to 18 years of age

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Comparison 3. Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Total Fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.2 Non‐vertebral fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.2.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.3 Vertebral fractures Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.3.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.4 % change in BMD, lumbar spine, DXA Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.4.1 24 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.5 % change in BMD, femur, DXA Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.5.1 24 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.6 Bone pain Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.6.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.7 Withdrawals, due to adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.8 Withdrawals, total Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.8.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.9 Survival Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.9.1 24 months	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Bisphosphonates versus control (with lung transplantation) ‐ adults (18 years and over)

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