Finkelstein 1999.
Study characteristics | ||
Methods | Trial design: Randomised controlled trial | |
Participants | Participants: 38 women were randomised and analysed. Mean age: Group 1: 34 ± 7 years, group 2: 34 ± 7 years Inclusion criteria:
Exclusion criteria:
Setting: United States of America Timing: not stated |
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Interventions | Nafarelin acetate (Synarel, Syntex Laboratories, Inc., Palo Alto, CA; 200 mg, intranasally, twice daily) (group 1; n = 28) versus Nafarelin acetate plus human PTH [40 mg (500 U), sc, daily] for 6–12 months (group 2; n = 23) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: This work was supported by NIH Grants R29‐DK‐43341 and RR1066 and a NIH Clinical Associate Physician Award (to J.S.F.). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The women were randomly assigned using computer generated cards. |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
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 |