Eastell R, Hannon RA, Wenderoth D, et al. Effect of Stopping Risedronate after Long-TermTreatment on Bone Turnover. Journal of Clinical Endocrinology and Metabolism 2011;96(11):3367–73-67–73.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/21865359
Full text article: https://academic.oup.com/jcem/article/96/11/3367/2834357
| Methods | Study design: Prospective cohort study as an extension of a randomized controlled trial
Number of groups: Two groups |
| Participants | Number of participants: 61 enrolled, 60 completed
· Risedronate 7 years deprescribed group: 31 enrolled · Risedronate 2 years deprescribed group: 30 enrolled Age: 66.9 ± 6,2 years Sex: 61 female, 0 male Participants with dementia: No Inclusion criteria: · Female · At least 5 years post-menopausal · No more than 85 years of age · Had at least two vertebral fractures (T4–L4, inclusive) at baseline Exclusion criteria: · Conditions that might interfere with evaluation of spinal osteoporosis · Use of calcitonin, calcitriol or vitamin D supplements within 1 month, anabolic steroids, estrogen, estrogen-related drugs or progestogen within 3 months · Bisphosphonates, fluoride or subcutaneous estrogen implant within 6 months · Participants completing 7 years of treatment if: o Less than 60% compliant with study drug during the previous extension o Started or continued a bisphosphonate, glucocorticoid, anabolic steroid, calcitonin, fluoride, vitamin D, calcitriol, or hormone therapy between completion of the second extension (year 2) and entry into year 8 of the study Concurrent medicine: “elemental calcium (1 g daily) throughout the study. Patients who required vitamin D supplementation, according to the investigator’s medical judgment, received vitamin D supplements (up to 500 IU/d) throughout the trial.” Country: 80 European and Australian centers Setting: Community |
| Interventions | Medicine: Risedronate 5mg daily
Withdrawal schedule: Not stated Comparator: Risedronate therapy for two years then ceased compared to risedronate therapy for seven years then ceased |
| Outcomes | Adverse events
Bone Mass Density changes from baseline Bone markers change from baseline |
| Dates | Dates: Not described
Follow-up duration: Three or eight years total: Two or seven years risedronate treatment, one yearof deprescribing |
| Funding sources | This study and writing/editorial support were funded by Warner Chilcott (US) LLC and Sanofi. R.E. receives research funding and consults for Warner Chilcott (US) LLC and Sanofi and is partly funded by the National Institute of Health Research as Senior Investigator. R.A.H. has received funding from Warner Chilcott (U.S.) LLC and Sanofi. D.W. is an employee of Warner Chilcott Deutschland GmbH. J.R.M. has no relevant financial relationships to disclose. A.S. has no relevant financial relationships to disclose. |
| Notes | The authors stated: “The authors were fully responsible for all content, editorial decisions, and opinions expressed in this manuscript. The authors received no form of compensation related to the development of the manuscript.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | This was an extension of a randomized study, but not randomized. |
| Allocation concealment (selection bias) | High risk | The original studies were blinded, but not the current extension. |
| Blinding of participants and personnel (performance bias) | Unclear risk | As above. |
| Blinding of outcome assessment (detection bias) | Unclear risk | As above. |
| Incomplete outcome data (attrition bias) | Unclear risk | There is no information about which group the patient who dropped out was from, or why. |
| Selective reporting (reporting bias) | 5 out of 5 | The study appears to be opportunistic rather than carefully thought out in advance. No pre-specified outcomes for this extension |
| Confounding (non-randomized) | Unclear risk | Not enough information to determine baseline factors (e.g. such as comparisons in fractures, baseline Bone Mass Density before treatment) |
| Other bias | High risk | Industry-sponsored. This study and writing/editorial support were funded by Warner Chilcott (US) LLC and Sanofi. R.E. receives research funding and consults for Warner Chilcott (US) LLC and Sanofi and is partly funded by the National Institute of Health Research as Senior Investigator. R.A.H. has received funding from Warner Chilcott (U.S.) LLC and Sanofi. D.W. is an employee of Warner Chilcott DeutschlandGmb |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Truly representative of the average older female with previous vertebral fractures in the community. |
| Selection of the non-exposed cohort | The non-exposed cohort was drawn from a different population (i.e. a different treatment arm) of the parent study. | |
| Ascertainment of exposure | Ascertainment of exposure is by secure record. | |
| Demonstration that outcome of interest was not present at start of study | It was demonstratedthat the outcome of interest was not present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The studycontrols for the duration of risedronate use. |
| Outcome bias | Assessment of outcome | Assessment of outcome was by record linkage. |
| Was follow-up long enough for outcomes to occur | Follow-upduration was probably inadequate for outcomes to occur. | |
| Adequacy of follow-up of cohorts | The follow-up of participants was probably adequate as a small number of subjects were lost to follow-upand those who were lost were adequately described. | |
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