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. 2024 Apr 9;4(4):CD003376.
doi: 10.1002/14651858.CD003376.pub4.

Etidronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

George A Wells  1 , Shu-Ching Hsieh  2 , Joan Peterson  3 , Carine Zheng  4 , Shannon E Kelly  5 , Beverley Shea  6 , Peter Tugwell  7
Affiliations

Etidronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

George A Wells et al. Cochrane Database Syst Rev. .

Abstract

Background: Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Etidronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts - bone cells that break down bone tissue. This is an update of a Cochrane review first published in 2008. For clinical relevance, we investigated etidronate's effects on postmenopausal women stratified by fracture risk (low versus high).

Objectives: To assess the benefits and harms of intermittent/cyclic etidronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.

Search methods: We searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE, Embase, two clinical trial registers, the websites of drug approval agencies, and the bibliographies of relevant systematic reviews. We identified eligible trials published between 1966 and February 2023.

Selection criteria: We included randomized controlled trials that assessed the benefits and harms of etidronate in the prevention of fractures for postmenopausal women. Women in the experimental arms must have received at least one year of etidronate, with or without other anti-osteoporotic drugs and concurrent calcium/vitamin D. Eligible comparators were placebo (i.e. no treatment; or calcium, vitamin D, or both) or another anti-osteoporotic drug. Major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events. We classified a study as secondary prevention if its population fulfilled one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (≤ -2.5), or aged 75 years or older. If none of these criteria were met, we considered the study to be primary prevention.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. The review has three main comparisons: (1) etidronate 400 mg/day versus placebo; (2) etidronate 200 mg/day versus placebo; (3) etidronate at any dosage versus another anti-osteoporotic agent. We stratified the analyses for each comparison into primary and secondary prevention studies. For major outcomes in the placebo-controlled studies of etidronate 400 mg/day, we followed our original review by defining a greater than 15% relative change as clinically important. For all outcomes of interest, we extracted outcome measurements at the longest time point in the study.

Main results: Thirty studies met the review's eligibility criteria. Of these, 26 studies, with a total of 2770 women, reported data that we could extract and quantitatively synthesize. There were nine primary and 17 secondary prevention studies. We had concerns about at least one risk of bias domain in each study. None of the studies described appropriate methods for allocation concealment, although 27% described adequate methods of random sequence generation. We judged that only 8% of the studies avoided performance bias, and provided adequate descriptions of appropriate blinding methods. One-quarter of studies that reported efficacy outcomes were at high risk of attrition bias, whilst 23% of studies reporting safety outcomes were at high risk in this domain. The 30 included studies compared (1) etidronate 400 mg/day to placebo (13 studies: nine primary and four secondary prevention); (2) etidronate 200 mg/day to placebo (three studies, all secondary prevention); or (3) etidronate (both dosing regimens) to another anti-osteoporotic agent (14 studies: one primary and 13 secondary prevention). We discuss only the etidronate 400 mg/day versus placebo comparison here. For primary prevention, we collected moderate- to very low-certainty evidence from nine studies (one to four years in length) including 740 postmenopausal women at lower risk of fractures. Compared to placebo, etidronate 400 mg/day probably results in little to no difference in non-vertebral fractures (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.20 to 1.61); absolute risk reduction (ARR) 4.8% fewer, 95% CI 8.9% fewer to 6.1% more) and serious adverse events (RR 0.90, 95% CI 0.52 to 1.54; ARR 1.1% fewer, 95% CI 4.9% fewer to 5.3% more), based on moderate-certainty evidence. Etidronate 400 mg/day may result in little to no difference in clinical vertebral fractures (RR 3.03, 95% CI 0.32 to 28.44; ARR 0.02% more, 95% CI 0% fewer to 0% more) and withdrawals due to adverse events (RR 1.41, 95% CI 0.81 to 2.47; ARR 2.3% more, 95% CI 1.1% fewer to 8.4% more), based on low-certainty evidence. We do not know the effect of etidronate on hip fractures because the evidence is very uncertain (RR not estimable based on very low-certainty evidence). Wrist fractures were not reported in the included studies. For secondary prevention, four studies (two to four years in length) including 667 postmenopausal women at higher risk of fractures provided the evidence. Compared to placebo, etidronate 400 mg/day may make little or no difference to non-vertebral fractures (RR 1.07, 95% CI 0.72 to 1.58; ARR 0.9% more, 95% CI 3.8% fewer to 8.1% more), based on low-certainty evidence. The evidence is very uncertain about etidronate's effects on hip fractures (RR 0.93, 95% CI 0.17 to 5.19; ARR 0.0% fewer, 95% CI 1.2% fewer to 6.3% more), wrist fractures (RR 0.90, 95% CI 0.13 to 6.04; ARR 0.0% fewer, 95% CI 2.5% fewer to 15.9% more), withdrawals due to adverse events (RR 1.09, 95% CI 0.54 to 2.18; ARR 0.4% more, 95% CI 1.9% fewer to 4.9% more), and serious adverse events (RR not estimable), compared to placebo. Clinical vertebral fractures were not reported in the included studies.

Authors' conclusions: This update echoes the key findings of our previous review that etidronate probably makes or may make little to no difference to vertebral and non-vertebral fractures for both primary and secondary prevention.

PubMed Disclaimer

Conflict of interest statement

None at present.

This review was updated without the support of any industry sponsor.

Figures

1
1
Hierarchical classification algorithm for primary and secondary prevention trials
2
2
Study flow diagram
3
3
Risk of bias summary: review authors' judgments about each risk of bias item for each included study (30 eligible studies).
4
4
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies (30 eligible studies).
1.1
1.1. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 1: Clinical vertebral fractures
1.2
1.2. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 2: Non‐vertebral fractures
1.3
1.3. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 3: Hip fractures
1.4
1.4. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 4: Wrist fractures
1.5
1.5. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 5: Radiographic vertebral fractures
1.6
1.6. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 6: Withdrawals due to adverse events
1.7
1.7. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 7: Serious adverse events
1.8
1.8. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 8: Gastrointestinal adverse events
1.9
1.9. Analysis
Comparison 1: Etidronate 400 mg/day versus placebo ‐ base case analysis, Outcome 9: Atypical femoral fractures
2.1
2.1. Analysis
Comparison 2: Etidronate 400 mg/day versus placebo ‐ subgroup of 1‐year studies, Outcome 1: Radiographic vertebral fractures
3.1
3.1. Analysis
Comparison 3: Etidronate 400 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 1: Clinical vertebral fractures
3.2
3.2. Analysis
Comparison 3: Etidronate 400 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 2: Non‐vertebral fractures
3.3
3.3. Analysis
Comparison 3: Etidronate 400 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 3: Hip fractures
3.4
3.4. Analysis
Comparison 3: Etidronate 400 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 4: Radiographic vertebral fractures
4.1
4.1. Analysis
Comparison 4: Etidronate 400 mg/day versus placebo ‐ subgroup of 3‐year studies, Outcome 1: Non‐vertebral fractures
4.2
4.2. Analysis
Comparison 4: Etidronate 400 mg/day versus placebo ‐ subgroup of 3‐year studies, Outcome 2: Hip fractures
4.3
4.3. Analysis
Comparison 4: Etidronate 400 mg/day versus placebo ‐ subgroup of 3‐year studies, Outcome 3: Wrist fractures
4.4
4.4. Analysis
Comparison 4: Etidronate 400 mg/day versus placebo ‐ subgroup of 3‐year studies, Outcome 4: Radiographic vertebral fractures
5.1
5.1. Analysis
Comparison 5: Etidronate 400 mg/day versus placebo ‐ subgroup of 4‐year studies, Outcome 1: Non‐vertebral fractures
5.2
5.2. Analysis
Comparison 5: Etidronate 400 mg/day versus placebo ‐ subgroup of 4‐year studies, Outcome 2: Hip fractures
5.3
5.3. Analysis
Comparison 5: Etidronate 400 mg/day versus placebo ‐ subgroup of 4‐year studies, Outcome 3: Wrist fractures
5.4
5.4. Analysis
Comparison 5: Etidronate 400 mg/day versus placebo ‐ subgroup of 4‐year studies, Outcome 4: Radiographic vertebral fractures
6.1
6.1. Analysis
Comparison 6: Etidronate 400 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 1: Clinical vertebral fractures
6.2
6.2. Analysis
Comparison 6: Etidronate 400 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 2: Non‐vertebral fractures
6.3
6.3. Analysis
Comparison 6: Etidronate 400 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 3: Hip fractures
6.4
6.4. Analysis
Comparison 6: Etidronate 400 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 4: Wrist fractures
6.5
6.5. Analysis
Comparison 6: Etidronate 400 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 5: Radiographic vertebral fractures
7.1
7.1. Analysis
Comparison 7: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 1: Clinical vertebral fractures
7.2
7.2. Analysis
Comparison 7: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 2: Non‐vertebral fractures
7.3
7.3. Analysis
Comparison 7: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 3: Hip fractures
7.4
7.4. Analysis
Comparison 7: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 4: Wrist fractures
7.5
7.5. Analysis
Comparison 7: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 5: Radiographic vertebral fractures
8.1
8.1. Analysis
Comparison 8: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 1: Non‐vertebral fractures
8.2
8.2. Analysis
Comparison 8: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 2: Hip fractures
8.3
8.3. Analysis
Comparison 8: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 3: Wrist fractures
8.4
8.4. Analysis
Comparison 8: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 4: Radiographic vertebral fractures
9.1
9.1. Analysis
Comparison 9: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding primary/secondary studies defined by age alone, Outcome 1: Clinical vertebral fractures
9.2
9.2. Analysis
Comparison 9: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding primary/secondary studies defined by age alone, Outcome 2: Non‐vertebral fractures
9.3
9.3. Analysis
Comparison 9: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding primary/secondary studies defined by age alone, Outcome 3: Hip fractures
9.4
9.4. Analysis
Comparison 9: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding primary/secondary studies defined by age alone, Outcome 4: Wrist fractures
9.5
9.5. Analysis
Comparison 9: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding primary/secondary studies defined by age alone, Outcome 5: Radiographic vertebral fractures
10.1
10.1. Analysis
Comparison 10: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding studies applying an ADFR regimen, Outcome 1: Clinical vertebral fractures
10.2
10.2. Analysis
Comparison 10: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding studies applying an ADFR regimen, Outcome 2: Non‐vertebral fractures
10.3
10.3. Analysis
Comparison 10: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding studies applying an ADFR regimen, Outcome 3: Hip fractures
10.4
10.4. Analysis
Comparison 10: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding studies applying an ADFR regimen, Outcome 4: Wrist fractures
10.5
10.5. Analysis
Comparison 10: Etidronate 400 mg/day versus placebo ‐ sensitivity analyses excluding studies applying an ADFR regimen, Outcome 5: Radiographic vertebral fractures
11.1
11.1. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 1: Hip fractures
11.2
11.2. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 2: Wrist fractures
11.3
11.3. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 3: Radiographic vertebral fractures
11.4
11.4. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 4: Withdrawals due to adverse events
11.5
11.5. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 5: Serious adverse events
11.6
11.6. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 6: Gastrointestinal adverse events
11.7
11.7. Analysis
Comparison 11: Etidronate 200 mg/day versus placebo ‐ base case analysis, Outcome 7: Atypical femoral fractures
12.1
12.1. Analysis
Comparison 12: Etidronate 200 mg/day versus placebo ‐ subgroup of 1‐year studies, Outcome 1: Radiographic vertebral fractures
13.1
13.1. Analysis
Comparison 13: Etidronate 200 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 1: Hip fractures
13.2
13.2. Analysis
Comparison 13: Etidronate 200 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 2: Wrist fractures
13.3
13.3. Analysis
Comparison 13: Etidronate 200 mg/day versus placebo ‐ subgroup of 2‐year studies, Outcome 3: Radiographic vertebral fractures
14.1
14.1. Analysis
Comparison 14: Etidronate 200 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 1: Hip fractures
14.2
14.2. Analysis
Comparison 14: Etidronate 200 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 2: Wrist fractures
14.3
14.3. Analysis
Comparison 14: Etidronate 200 mg/day versus placebo ‐ subgroup of bisphosphonate‐naïve participants, Outcome 3: Radiographic vertebral fractures
15.1
15.1. Analysis
Comparison 15: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 1: Hip fractures
15.2
15.2. Analysis
Comparison 15: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 2: Wrist fractures
15.3
15.3. Analysis
Comparison 15: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with baseline denominators, Outcome 3: Radiographic vertebral fractures
16.1
16.1. Analysis
Comparison 16: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 1: Hip fractures
16.2
16.2. Analysis
Comparison 16: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 2: Wrist fractures
16.3
16.3. Analysis
Comparison 16: Etidronate 200 mg/day versus placebo ‐ sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 3: Radiographic vertebral fractures
17.1
17.1. Analysis
Comparison 17: Clinical vertebral fractures, Outcome 1: Treatment versus reference, secondary
18.1
18.1. Analysis
Comparison 18: Non‐vertebral fractures, Outcome 1: Treatment versus reference, secondary
19.1
19.1. Analysis
Comparison 19: Hip fractures, Outcome 1: Treatment versus reference, secondary
20.1
20.1. Analysis
Comparison 20: Wrist fractures, Outcome 1: Treatment versus reference, secondary
21.1
21.1. Analysis
Comparison 21: Radiographic vertebral fractures, Outcome 1: Treatment versus reference, secondary
22.1
22.1. Analysis
Comparison 22: Withdrawals due to adverse events, Outcome 1: Treatment versus reference, primary
22.2
22.2. Analysis
Comparison 22: Withdrawals due to adverse events, Outcome 2: Treatment versus reference, secondary
23.1
23.1. Analysis
Comparison 23: Serious adverse events, Outcome 1: Treatment versus reference, secondary
24.1
24.1. Analysis
Comparison 24: Gastrointestinal adverse events, Outcome 1: Treatment versus reference, secondary
25.1
25.1. Analysis
Comparison 25: Atypical femoral fracture, Outcome 1: Treatment versus reference, secondary
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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References to studies excluded from this review

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Iwamoto 2003a {published data only}
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Yamaguchi 2005 {published data only}
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Zhu 2004 {published data only}
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References to studies awaiting assessment

Clemente 1996 {published data only}
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Dogan 2001 {published data only}
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JapicCTI‐050093 {published data only}
    1. JapicCTI-050093. A comparison of incidences of vertebral fracture in Japanese patients with osteoporosis treated with etidronate and alfacalcidol; a randomized, double-blind study. rctportal.niph.go.jp/s/detail/um?trial_id=JapicCTI-050093# (first received 13 September 2005).
Lozano‐Tonkin 1996 {published data only}
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References to other published versions of this review

Wells 2006b
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