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Bisphosphonates, teriparatide and deno-sumab for the treatment of postmenopausal osteoporosis1
Institute for Quality and Efficiency in Health Care (IQWiG).
Key statements
Research question:
The objective of this investigation is to assess the benefit of bisphosphonates, teriparatide, and denosumab in comparison with each other in the treatment of women with postmenopausal osteoporosis with regard to patient-relevant outcomes.
The research question includes an assessment of bisphosphonates in comparison with each other.
Conclusion:
Given the available evidence, the following individual comparisons were taken into account in the benefit as-sessment: denosumab versus bisphosphonates, teriparatide versus risedronate as well as bisphosphonates in com-parison with each other.
For risedronate, the data transmission by the manufacturer was incomplete. Publication bias likely arose with respect to the risedronate intervention. Consequently, no proof, indication, or hint of benefit or harm is derived for the intervention of risedronate (except for a hint of lesser benefit from the comparison of teriparatide versus risedronate). In the comparison of teriparatide versus risedronate, the incompleteness of the manufacturer docu-ments was irrelevant because all studies were available on this comparison.
The available evidence for patient-relevant outcomes is deemed limited overall. The available evidence was insufficient, particularly for the outcomes of pain, functional limitations, health-related quality of life, osteonecrosis of the jaw, and symptomatic atypical femoral fractures.
Comparison of denosumab versus bisphosphonates:
For the comparison of denosumab versus bisphosphonates, the available data allow drawing robust conclu-sions only in comparison with the drug zoledronate.
The evidence shows the following:
- No hint of greater benefit or harm resulted from the available data for the outcomes of all-cause mortality, fractures in the hip area, distal radius fractures, symptomatic vertebral fractures, nonvertebral symptomatic fractures, serious adverse events (SAEs), discontinuation due to adverse events (AEs) as well as AEs and SAEs of the gastrointestinal tract.
- For the outcomes of pain, functional limitations, health-related quality of life, osteonecrosis of the jaw, and symptomatic atypical femoral fractures, no data usable for the comparison of denosumab versus bisphosphonates were available; therefore, no hint of greater benefit or harm resulted for any of them.
In the overall weighing of benefit and harm, there was no hint of greater or lesser benefit or harm for treatment with denosumab in comparison with zoledronate across outcomes.
Comparison of teriparatide versus risedronate:
For the comparison of teriparatide versus risedronate, which can be conducted given the available data, the evidence shows the following:
- For the outcome of symptomatic vertebral fractures, there was a hint of greater benefit of teriparatide ver-sus risedronate.
- For the outcome of AEs of the gastrointestinal tract, there was a hint of greater harm from teriparatide ver-sus risedronate.
- No hint of greater benefit or harm was found on the basis of the available data for the outcomes of all-cause mortality, fractures in the hip area, distal radius fractures, nonvertebral symptomatic fractures, pain, SAEs, discontinuation due to AEs, osteonecrosis of the jaw, and symptomatic atypical femoral fractures as well as SAEs of the gastrointestinal tract.
- No data were available for the outcomes of functional limitations or health-related quality of life; this re-sulted in no hint of greater harm or benefit.
Overall, the favourable effect for teriparatide in comparison with risedronate in the outcome of symptomatic vertebral fractures is therefore contrasted by an unfavourable effect for teriparatide in comparison with risedronate in the outcome of AEs of the gastrointestinal tract. Given the fact that the outcome of symptomatic vertebral frac-tures showed a substantial effect in favour of teriparatide (upper limit of the 95% confidence interval: 0.58), while the disadvantage was marginal in the outcome of AEs of the gastrointestinal tract (95% confidence interval: [1.01; 1.57]) and not present in SAEs of the gastrointestinal tract, the overall weighing of benefit and harm across out-comes resulted in a hint of greater benefit of teriparatide versus risedronate.
Bisphosphonates in comparison with each other:
For the comparison of bisphosphonates with each other, robust conclusions based on the available data can be drawn only for the drugs of alendronate and ibandronate.
The evidence shows the following:
- No hint of greater benefit or harm was found based on the available data for the outcomes of fractures in the hip area, distal radius fractures, nonvertebral symptomatic fractures, SAEs, discontinuation due to AEs, or AEs and SAEs of the gastrointestinal tract.
- No data were available for the outcomes of all-cause mortality, symptomatic vertebral fractures, pain, func-tional limitations, health-related quality of life, osteonecrosis of the jaw, and symptomatic atypical femoral frac-tures; this resulted in no hint of greater benefit or harm for any of them.
In the overall weighing of benefit and harm, there was no hint of greater or lesser benefit or harm of alendro-nate versus ibandronate across outcomes.
Keywords:
Diphosphonates, Alendronate, Ibandronic Acid, Risedronic Acid, Zoledronic Acid, Teriparatide, Denosumab, Osteoporosis – Postmenopausal Benefit Assessment, Systematic ReviewContents
Publishing details
Publisher
Institute for Quality and Efficiency in Health Care
Topic
Bisphosphonates, teriparatide and denosumab for the treatment of postmenopausal osteoporosis
Commissioning agency
Federal Joint Committee
Commission awarded on
17 January 2019
Internal Commission No.
A19-10
Address of publisher
This report was prepared in collaboration with external experts.
The responsibility for the contents of the report lies solely with IQWiG.
According to §139b (3) No. 2 of Social Code Book (SGB) V, Statutory Health Insurance, external experts who are involved in the Institute’s research commissions must disclose “all connections to interest groups and contract organizations, particularly in the pharmaceutical and medical devices industries, including details on the type and amount of any remuneration received”. The Institute received the completed Form for disclosure of potential conflicts of interest from each external expert. The information provided was reviewed by a Committee of the Institute specifically established to assess conflicts of interests. The information on conflicts of interest provided by the external experts and external reviewers is presented in Chapter A14 of the full report. No conflicts of interest were detected that could endanger professional independence with regard to the work on the present commission.
External experts
- Dietmar Krause, Department of Medical Informatics, Statistics and Epidemiology, Ruhr University Bochum / Gladbeck Internal Medicine and Rheumatology Group Practice, Germany
IQWiG thanks the external expert for his collaboration in the project.
Patient involvement
Patients were consulted as part of the report preparation process.
Gisela Klatt took part in the discussion.
IQWiG would like to thank her for her participation in the discussion about her experience of the disease, treatment experiences and treatment goals. She was not involved in the actual report preparation.
IQWiG employees
- Marina Woeste
- Katharina Hirsch
- Petra Kohlepp
- Katrin Nink
- Regine Potthast
- Annette Pusch-Klein
- Christoph Schürmann
- Claudia Selbach
- Dorothea Sow
- Katharina Wölke
- 1
Translation of Chapters 1 to 6 of the final report A19-10 Bisphosphonate, Teriparatid und Deno-sumab zur Behandlung der postmenopausalen Osteoporose (Version 1.0; Status: 2 November 2022 [German original], 28 June 2023 [English translation]). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding.
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