Efficacy of Zoledronic Acid in Maintaining Areal and Volumetric Bone Density After Combined Denosumab and Teriparatide Administration: DATA‐HD Study Extension

• Published in: Journal of bone and mineral research 2021-05, Vol.36 (5), p.921-930
• Main Authors: Ramchand, Sabashini K, David, Natalie L, Lee, Hang, Eastell, Richard, Tsai, Joy N, Leder, Benjamin Z
• Format: Article
• Language: English
• Subjects: Acids; ANABOLICS; ANALYSIS/QUANTITATION OF BONE; ANTIRESORPTIVES; Bone Density; Bone Density Conservation Agents; Bone loss; Bone mineral density; BONE QCT/μCT; Bone turnover; Denosumab; DISEASES AND DISORDERS OF/RELATED TO BONE; Dosage; DXA; Female; Femur; Femur Neck - diagnostic imaging; Fractures; Hip; Humans; Middle Aged; Monoclonal antibodies; OSTEOPOROSIS; Osteoporosis, Postmenopausal - diagnostic imaging; Osteoporosis, Postmenopausal - drug therapy; Parathyroid hormone; Post-menopause; Teriparatide - pharmacology; THERAPEUTICS; Zoledronic Acid
• ISSN: 0884-0431; 1523-4681
• DOI: 10.1002/jbmr.4259

ABSTRACT Combined teriparatide and denosumab rapidly and substantially increases bone mineral density (BMD) at all anatomic sites. Discontinuation of denosumab however, results in high‐turnover bone loss and increased fracture risk. The optimal way to prevent this bone loss remains undefined. This study is a preplanned extension of the DATA‐HD study, where postmenopausal women with osteoporosis were randomized to receive 9 months of either 20 μg or 40 μg of teriparatide daily overlapping with denosumab (60 mg administered at months 3 and 9). At the completion of this 15‐month study, women were invited to enroll in the DATA‐HD Extension where they received a single dose of zoledronic acid (5 mg) 24 to 35 weeks after the last denosumab dose. Areal BMD and bone turnover markers were measured at month 27 and 42 (12 and 27 months after zoledronic acid, respectively) and spine and hip volumetric bone density by quantitative CT was measured at month 42. Fifty‐three women enrolled in the DATA‐HD Extension. At the femoral neck and total hip, the mean 5.6% and 5.1% gains in BMD achieved from month 0 to 15 were maintained both 12 and 27 months after zoledronic acid administration. At the spine, the mean 13.6% gain in BMD achieved from month 0 to 15 was maintained for the first 12 months but modestly decreased thereafter, resulting in a 3.0% reduction (95% CI, −4.0% to −2.0%, p