A Randomized Double-Blind Trial to Compare the Efficacy of Teriparatide [Recombinant Human Parathyroid Hormone (1–34)] with Alendronate in Postmenopausal Women with Osteoporosis

• DOI: 10.1210/jc.2002-020334
• Publication Date: 2002-10-03T19:06:01Z
• Authors: Jean-Jacques Body; Gregory A. Gaich; Wim H. Scheele; Pandurang M. Kulk...; Paul D. Miller; Anne Peretz; Robin K. Dore; Ricardo Correa-Ro...; Alexandra Papaioa...; David C. Cumming; Anthony B. Hodsman
• Keywords: Adult; Calcitriol -- blood; Bone -- prevention & control; Bone and Bones; Collagen Type I; Fractures, Bone; 03 medical and health sciences; Bone Remodeling -- drug effects; 0302 clinical medicine; Calcitriol; Double-Blind Method; Bone Density; Collagen -- urine; 80 and over; Humans; Postmenopausal -- drug therapy; Body Height -- drug effects; Bone Resorption; Bone and Bones -- enzymology -- injuries; Osteoporosis, Postmenopausal; Aged; Aged, 80 and over; Alendronate; Bone Density -- drug effects; Alkaline Phosphatase -- blood; Teriparatide -- therapeutic use; Alendronate -- therapeutic use; Middle Aged; Alkaline Phosphatase; Body Height; 3. Good health; Cancérologie; Bone Resorption -- prevention & control; Osteoporosis; Biological Markers; Female; Bone Remodeling; Collagen; Fractures; Peptides -- urine; Biomarkers

Teriparatide (rDNA origin) injection [recombinant human PTH (1–34)] stimulates bone formation, increases bone mineral density (BMD), and restores bone architecture and integrity. In contrast, bisphosphonates reduce bone resorption and increase BMD. We compared the effects of teriparatide and alendronate sodium on BMD, nonvertebral fracture incidence, and bone turnover in 146 postmenopausal women with osteoporosis. Women were randomized to either once-daily sc injections of teriparatide 40 μg plus oral placebo (n = 73) or oral alendronate 10 mg plus placebo injection (n = 73). Median duration of treatment was 14 months. At 3 months, teriparatide increased lumbar spine BMD significantly more than did alendronate (P < 0.001). Lumbar spine-BMD increased by 12.2% in the teriparatide group and 5.6% in the alendronate group (P < 0.001 teriparatide vs. alendronate). Teriparatide increased femoral neck BMD and total body bone mineral significantly more than did alendronate, but BMD at the one third distal radius decreased, compared with alendronate (P ≤ 0.05). Nonvertebral fracture incidence was significantly lower in the teriparatide group than in the alendronate group (P < 0.05). Both treatments were well tolerated despite transient mild asymptomatic hypercalcemia with teriparatide treatment. In conclusion, teriparatide, a bone formation agent, increased BMD at most sites and decreased nonvertebral fractures more than alendronate.