A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
Status:
Completed
Trial end date:
2021-05-11
Target enrollment:
Participant gender:
Summary
This is a double-blinded randomized study to determine the effects of treatment on
biochemical markers of bone formation and bone resorption, and bone mineral density (BMD) for
6 months of treatment with EBP05 or placebo. Approximately 160 postmenopausal women with low
bone mass (BMD T-score lower than or equal to -2.0 in at least one location: Lumbar Spine,
Femoral Neck or Total Hip sites) over 50 years of age will receive Study Medication. Protocol
Version 3.0 describes the treatment and evaluation of the initial 103 subjects randomized. In
Protocol Version 4.0 the treatment phase will consist of 4 different treatment arms as
follows:
Oral EBP05 0.5mg x3 tablets (1.5mg), N=6 Oral EBP05 0.5mg x5 tablets (2.5mg), N=36 Oral
Placebo for EBP05 0.5mg (split to sub-groups of: 3 or 5 tablets), N=18