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A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass

NCT04003467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-06-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

EBP05

tablets

DRUG

Placebo of EBP05

tablets

Sponsors & Collaborators

  • Entera Bio Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Santora, MD · Entera Bio Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-04-27
Completion
2021-05-11

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003467 on ClinicalTrials.gov