Chevrel 2006.

Methods	Single‐centre, double‐blinded, placebo‐controlled RCT. Parallel trial.
Participants	64 adults (39 males) were randomised. Age range: > 20 years (treatment: mean (SD) 37 (12); placebo mean (SD) 36 (12). All types of OI.
Interventions	Oral alendronate vs placebo. Dosage: 10 mg. Trial period: 36 months. Participants seen at baseline and during the 3 years of the trial: every year in Lyon with intermediary visits at months 6, 18, and 30 by their local physician. BMD of the lumbar spine and of both hips (total femur) was measured at baseline and at 12, 24, and 36 months. Radiographs of the spine (anteroposterior and lateral views) were obtained at baseline and 36 months. Overall pain score was evaluated at baseline and every 6 months during 3 years with a visual analog scale score (0 – 10). Each participant underwent audiometry and impedancometry at baseline and at 36 months.
Outcomes	Dietary calcium intake, spine BMD, hip BMD, spine radiographs, fractures, pain score, audiometry, impedancometry, serum and urine samples for biochemical markers of bone turnover, transiliac bone biopsies.
Notes	Allocation intervention ‐ adequate. Computer‐generated list. Not adequately powered for fracture outcome.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list was drawn up by the pharmacy department
Allocation concealment (selection bias)	Low risk	Allocation was concealed by giving the randomised list to the researchers who then assigned each new trial subject the subsequent number on the list
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blinded (trial personnel and participants)
Incomplete outcome data (attrition bias) All outcomes	Low risk	An intention‐to‐treat analyses were performed.  BMD follow up was complete for 62 randomised participants, including the 3 in the alendronate group and 1 in the placebo group who withdrew from the trial for personal reasons without drug related adverse effects.
Selective reporting (reporting bias)	Low risk	Outcomes are reported.
Other bias	Unclear risk	Not adequately powered for fracture outcome.