Leder BZ, Neer RM, Wyland JJ, et al. Effects of Teriparatide Treatment and Discontinuation in Postmenopausal Women and Eugonadal Men with Osteoporosis. Journal of Clinical Endocrinology and Metabolism 2009;94(8):2915–21-15–21
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/19435827
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730878/
| Methods | Study design: Comparative study with two-single arms
Number of groups: Two groups |
| Participants | Number of participants: 17 of 31 women enrolled in the original study completed to be enrolled in the current study
14 of the 27 men enrolled in the original study completed it to be enrolled in the current study · Female deprescribing group: 17 enrolled, · Male deprescribing group: 14 enrolled Age: Females: 65 ± 7 years. Males: 57 ± 9 years Sex: 14 female, 17 male Participants with dementia: No Inclusion criteria: · 46 to 85 year old · Bone Mass Density of the lumbar spine in the posterior-anterior (PA) or lateral projection or the femoral neck at least 2 SD values below the mean of gender matched young adults (T-score 2) · Serum calcium level below 10.6 mg/dl · Serum creatinine below 2 mg/dl · Serum alkaline phosphatase below 150 U/liter · Serum 25-hydroxyvitamin D above 15 ng/ml · Normal serum Parathyroid Hormone and Thyroid-Stimulating Hormone levels · In men, the serum testosterone level was required to be at least 270 ng/dl the lower limit of normal in the assay · In women, were required to be at least 5 year removed from surgical or natural menopause Exclusion criteria: · Disorders or taking medications known to affect bone metabolism · Nephrolithiasis · Peptic-ulcer disease · Severe reflux esophagitis · Significant cardiac disease · Malignancy (with the exception of basal cell skin cancer) Concurrent medicine: 400 IU of vitamin D daily, and calcium intake was estimated by a research dietician at baseline and periodically during months 0–42 and was maintained at 1000 to 1200 mg daily through diet and/or supplements Country: United States of America Setting: Community |
| Interventions | Medicine: Teriparatide 37mcg subcutaneously daily
Withdrawal schedule: Not described Comparison: Younger males deprescribing teriparatide compared to older females deprescribing teriparatide and change over time |
| Outcomes | Bone Mass Density (PA spine, femoral neck, total hip, and trabecular spine)
Biochemical markers of bone turnover |
| Dates | Study dates: Not described
Follow-up duration: 42 months total: 6 months without treatment, 24 months teriparatide treatment, 12 months deprescribing |
| Funding sources | National Institutes of Health Grants P50 AR44855, RR-1066 and K24DK02759 (to J.S.F.). |
| Notes | Only include the data from females, as males are less than 65 years.
Authors stated: “Disclosure Summary: B.Z.L., H.W.L., J.J.W., S.A.B., and R.M.N. have nothing to declare. J.S.F. has been a consultant for Merck.”
Additional information sought, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not randomized. |
| Allocation concealment (selection bias) | High risk | Not blinded. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Not blinded. |
| Blinding of outcome assessment (detection bias) | 1 out of 5 | “All bone density scans were analyzed by individuals blinded to study treatment.” |
| Incomplete outcome data (attrition bias) | 1 out of 5 | There were no drop-outs. All participants were included in the analysis. |
| Selective reporting (reporting bias) | Unclear risk | It is unclear if they followed a pre-specified protocol or if this was an opportunistic extension. |
| Confounding (non-randomized) | Unclear risk | Two arms, but they are not true control groups. |
| Other bias | Low risk | Very specific biochemical tests – somewhat representative, but a small group so cannot be truly representative. |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of the person with severe osteoporosis in the community. |
| Selection of the non-exposed cohort | The two-single-arm studies were drawn from similar populations – both had been members of similar preceding trials.
|
|
| Ascertainment of exposure | As the participants had already been in a preceding clinical trial, ascertainment of exposure was by secure record (e.g. surgical records).
|
|
| Demonstration that outcome of interest was not present at start of study | They demonstrated that outcome of interest (deprescribing) was not present at start of study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study was not controlled, although there were two arms to the study. It was a two-single-arm study rather than a concurrent control group. |
| Outcome bias | Assessment of outcome | Outcomes were assessed by independent blind assessment. |
| Was follow-up long enough for outcomes to occur | With a follow-up of less than two years, it was probably insufficient for outcomes to occur. | |
| Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for. | |
Leave a Reply