Low dose zoledronate in postmenopausal women with thin bones

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2007
INTERVENTION: At the end of the original double blind 2 year protocol, all participants were invited to participate in a 2 year open‐label extension, during which no further study drug was administered to any participants. 4 years after administration of the baseline dose, all participants still in follow‐up were invited to enter a second open‐label extension. In the first year of this extension, no further study drug was administered. At 5 years, those who received 1mg or 2.5mg zoledornic acid were administered a second single identical dose. Participants who received placebo or 5mg zoledronic acid at baseline did not receive further study drug. Follow‐up is planned until 10 years after the baseline dose of study drug. CONDITION: Osteoporosis PRIMARY OUTCOME: Change in lumbar spine bone density SECONDARY OUTCOME: Biochemical markers of bone turnover will be assessed 6 monthly to annually during the open‐label extensions Total hip bone density will be assessed annually during the open‐label extensions INCLUSION CRITERIA: Postmenopausal women Bone density T Score < ‐1 and > ‐2.5 at lumbar spine or total hip
Epistemonikos ID: 40a4fe2408834e6ef0fa1bf46ddc31670680d756
First added on: Aug 21, 2024