Clinical trial of microcrystalline hydroxyapatite compound ('Ossopan') in the prevention of osteoporosis due to corticosteroid therapy.

A controlled clinical trial was carried out in 40 patients at risk of osteoporosis because of long-term treatment with prednisolone (5 to 20 mg/day) to determine the efficacy and tolerance of microcrystalline hydroxyapatite compound (MCHC) when used to prevent the appearance or progression of osteoporosis: 32 patients were treated with 6 to 8 g MCHC for 12 months and 8 served as an untreated control group. The two groups were well matched as regards age, sex and underlying disease; 37 patients (29 MCHC, 8 control) successfully completed the trial. The majority (68%) of the patients had back pain prior to the trial, the severity of which was graded at 3-monthly intervals. In the MCHC-treated group, there was a dramatic and significant (p less than 0.001) reduction in pain during the trial, almost to the point of its disappearance. Of 19 patients with initial back pain only 2 still reported any pain at all after 12-months' MCHC treatment. In the control group, back pain severity increased during the trial in 3 patients and was unchanged in the fourth. Neither MCHC-treated nor control group patients showed any significant change in standing or stem height during the 12-months' trial period. Both mean cortical thickness and mean metacarpal index figures showed small, insignificant decreases during 12-months' MCHC treatment but much more marked decreases in the control group which, despite the small number of patients, came close to being statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes