Finkelstein 1998.
Study characteristics | ||
Methods | Trial design: Randomised controlled trial | |
Participants | Participants: 43 women were randomised and 39 analysed. Mean age: Group 1: 31 ± 7 years, group 2: 32 ± 7 years Inclusion criteria:
Exclusion criteria:
Setting: United States of America Timing: not stated |
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Interventions | GnRH analog nafarelin acetate (Synarel, Syntex Laboratories, Inc, Palo Alto, Calif), 200 μg intranasally twice daily, for 12 months (group 1, n = 22) versus Nafarelin acetate plus human PTH‐(1‐34), 40 μg (500 U) subcutaneously daily, for 12 months (group 2, n = 21) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: yes Sample size calculation: not stated Funding: This work was supported by National Institutes of Health grants R29 DK43341 and RR1066 and a National of Institutes of Health Clinical Associate Physician Award (Dr Finkelstein). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was conducted by a research biostatistician not otherwise involved in the study. |
Allocation concealment (selection bias) | Low risk | The women were randomly assigned. Randomisation was performed using computer‐generated cards that were numbered sequentially and kept in opaque, sealed envelopes until entry into the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Because we and our local institutional review board felt that the use of placebo hPTH‐(1‐34) injections was unethical, no placebo was used. Thus, neither the patients nor the investigators were blinded with respect to treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The person reading the bone density scans, however, was blinded with respect to treatment assignment, as were the technicians who performed the biochemical analyses. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four women in group 2 (4/21) withdrew from the study after 3 months (n = 2) or 6 months (n = 2). Reasons for withdrawal included hot flashes and mild weight gain (n = 1), excessive distance from study site (n = 1), discomfort from injections (n = 1), and depression (n = 1). All data from these women are included and analysed with their originally assigned group. |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |