[Clinical study on combination of multiple regimens in treatment of osteoporosis in perimenopause and postmenopausal women]

Abstract

Objective: To evaluate clinical efficacy of multiple regimen combination in treatment of osteoporosis of perimenopausal or postmenopausal women.

Methods: From Jul. 2008 to Dec. 2009, 109 women with low bone mineral density (BMD) or osteoporosis treated in Department of Obstetrics and Gynecology, Affiliated Second Hospital, Wenzhou Medical College were enrolled randomly into 3 group, including 36 women in Group A managed by osteoform 1000 mg/d + alfacalcidol 0.25 µg/bid orally, 40 women in group B managed by osteoform 1000 mg/d + alfacalcidol 0.25 µg/bid + tibolone 1.25 mg/d orally and 33 women in group C managed by osteoform 1000 mg/d + alfacalcidol 0.25 µg/bid + bisphosphonates 70 mg/w orally. After 48 weeks BMD on lumbar 1-4 (L₁₋₄) and left femur were detected by X-ray. Bone alkaline phosphatase(BALP), cross linked clelopeptide of type I collagen (CTX) and 25-hydroxychole calciferol [25(OH)D₃] was measured by enzyme linked immunosorbent assay (ELISA).

Result: Seven women (6.4%, 7/109) were withdrawed form this study, including 2 cases losing follow up in group A, 3 cases stopping treatment in group B, 2 cases giving up treatment due to severe adverse effect (burning in upper abdomen) in group C. (1) Pain relieve: after 48 weeks treatment, women in 3 groups improved symptom of pain significantly, the rates of pain relieve were 85% (29/34) in group A, 92% (34/37) in group B and 94% (29/31) in group C. (2) BMD: BMD was improved significantly in women in 3 groups after treatment. BMD of L₁₋₄ were (0.88 ± 0.15) g/cm² in group A, (0.89 ± 0.18) g/cm² in group B and (0.87 ± 0.10) g/cm² in group C before treatment, and converted to (0.90 ± 0.01) g/cm² in group A, (0.93 ± 0.09) g/cm² in group B and (0.91 ± 0.11) g/cm² in group C after treatment. BMD of left femur were (0.87 ± 0.07) g/cm² in group A, (0.87 ± 0.07) g/cm² in group B and (0.85 ± 0.12) g/cm² in group C before treatment and converted to (0.90 ± 0.03) g/cm² in group A, (0.91 ± 0.08) g/cm² in group B and (0.89 ± 0.12) g/cm² in group C after treatment. It was shown significantly different BMD between group B or C and group A (P < 0.01), however, there was no significant different BMD between group B and C (P > 0.05). (3) Index of bone metabolism: BALP were (26 ± 6) µg/L in group A, (26 ± 9) µg/L in group B and (28 ± 7) µg/L in group C before treatment and converted to (22 ± 5) µg/L in group A, (20 ± 9) µg/L in group B and (22 ± 8) µg/L in group C after treatment, which showed statistical difference (P < 0.05). CTX were (0.85 ± 0.20) ng/L in group A, (0.84 ± 0.47) ng/L in group B, and (0.88 ± 0.11) ng/L in group C before treatment and converted to (0.81 ± 0.19) ng/L in group A, (0.77 ± 0.33) ng/L in group B, and (0.82 ± 0.14) ng/L in group C after treatment, which showed statistical difference (P < 0.05).

Conclusions: Those 3 regimens combination could be used in treatment of osteoporosis by decreasing bone conversion, increasing bone density, decreasing bone absorption. Regimen A was only suitable for basic therapy, the other two regimens could provide better treatment.