Study participants
fracture, amenorrhea, hypercalcemia, fractures, Osteoporosis, osteoporosis, diabetes
INTRAVENOUS BISPHOSPHONATES, HYPERCALCEMIA, METABOLIC DISEASES, OSTEOPOROSIS, OSTEOPOROSIS, VITAMIN D DEFICIENCY, HYPOCALCEMIA, METABOLIC BONE DISEASES, DIABETES
Eligible subjects were ambulatory women of postmenopausal status for at least 5 years, aged 50–70 years, with evidence of osteoporosis and body weight of no less than 40 kg. Postmenopausal status was defined as having ≥ 12 months of spontaneous amenorrhea or undergoing bilateral oophorectomy 6 weeks prior. Osteoporosis was defined as a BMD T-score ≤ -2.5 at the lumbar spine (L1–L4, one or more vertebrae), total hip, or femoral neck using the Asian normative database integrated with the Hologic dual energy X-ray absorptiometry (DXA) scanner. The subjects had to have at least two vertebrae in the L1–L4 region and at least one hip that could be evaluated using dual-energy X-ray absorptiometry. Key exclusion criteria included a history of hip fracture, any severe or more than two moderate vertebral fractures, a history of metabolic bone diseases (except for osteoporosis) or endocrine and metabolic diseases that may disturb bone metabolism, a T-score < -3.5, at lumbar spines (L1–L4, one or more vertebrae), total hip or femoral neck, vitamin D deficiency (25-hydroxyvitamin D [25-OHD] concentration < 20 ng/mL), diabetes inadequately controlled on diet and exercise (fasting plasma glucose ≥ 7.0 mmol/L or hemoglobin A1c ≥ 7.0%), and hypercalcemia or hypocalcemia. The use of the following agents was not allowed: intravenous bisphosphonates or denosumab at any time, oral bisphosphonates, PTH or its analogs, strontium or fluoride within the previous 12 months, long-acting estrogen/progesterone replacement therapy within the previous 6 months, systemic glucocorticoids, estrogen/progesterone replacement therapy, anabolic steroids, selective estrogen-receptor modulators, calcitonin, calcitriol and its analogs, and thiazide diuretics within the previous 3 months.