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. 2023 Mar 6;2023(3):MR000055. doi: 10.1002/14651858.MR000055.pub2

Solomon 1960.

Study characteristics
Methods Type: clinical
Design: cross‐over
Objective: to investigate psychologic and osteometabolic responses to sex hormones in elderly osteoporotic women
Treatment duration: 6 weeks per cross‐over period
Follow‐up duration (including treatment duration): 6 weeks per cross‐over period
Washout between cross‐over periods: not stated explicitly, but probably none
Data Country: USA
Condition: women with postmenopausal osteoporosis or Paget's disease
Number of people randomised: 12 randomised to a cross‐over sequence
Number of people analysed: all 12 completed, but unclear if all 12 analysed for each placebo
Comparisons Active placebo: dextroamphetamine and amobarbital (5 mg, twice daily)
Standard placebo: lactose
Experimental intervention: 2 groups: methallenestril (3 mg twice daily) and fluoxymesterone (5 mg twice a day)
Administration: oral
Outcomes Participant‐reported outcome: questionnaire covering 10 categories (household activities, social activities, resting, motor performance, sleeping, pain, psychological distress, well‐being, interest and participation in environment, and libidinal stimulation)
Observer‐reported outcome: 24 hour urinary calcium excretion
Harm outcome: none
Co‐intervention outcome: none
Terminology for active placebo "Active placebo" a priori
Scores and unpleasantness of the active placebo Adequacy: 2
Risk of therapeutic effect: 4
Unpleasant/neutral/pleasant: unpleasant
Funding and conflicts of interest Mixed; received drugs from companies. Conflicts of interest not reported.
Notes  
Risk of bias
Item Authors' judgement Support for judgement
Free from risk of bias arising from the randomisation process Unclear Completed Latin squares design. No other information.
Free from risk of bias in selection of the reported result
All outcomes Unclear No information.