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

What Was Tested

This registered phase 2 trial tested Teriparatide for osteoporosis and bone density.

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.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a double-blinded randomized study to determine the effects of treatment on biochemical markers of bone formation and bone resorption after 6 months of treatment with EBP05 or placebo.

Approximately 160 postmenopausal women with low bone mass (BMD T-score less 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 be enrolled.

Protocol Version 3.0 described the study design for the initial 103 subjects randomized.

The current Version 4.0 describes the study design for approximately 60 additional randomized subjects.

Who Took Part

The registry lists 161 actual participants took part.

It was open to women only aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female subjects above 50 years of age. Signed Informed Consent Form. Able to adhere to the visit schedule and protocol requirements. At least 3 years post menopause (physiological or surgical). Women who are less than 55 years old need to have estradiol and LH in the menopausal range.

The full record lists 6 inclusion and 32 exclusion criteria; among the exclusions: acute illness within 14 days of screening; history of paget's disease of bone; history of prior external beam or implant radiation therapy involving the skeleton.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-06-30 with completion listed for 2021-04-27.

It ran at 4 sites in Israel (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean % change in P1NP from baseline after 3 months of treatment (time frame: baseline, 3 months).

It also tracked 7 secondary outcomes, for example Mean % change in BMD (lumbar) from baseline after 6 months of treatment, Mean % change in BMD (Femoral Neck and Total Hip) from baseline after 6 months of treatment, Mean % change in P1NP from baseline after 6 months of treatment, Mean % change in osteocalcin and bone alkaline phosphatase from baseline after 6 months of treatment, Mean % change in serum CTX and urine NTX/Creatinine from baseline after 3 months of treatment and Concentration of plasma hPTH(1-34) 15 min after Study Medication administration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 161 people with osteoporosis and bone density.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, Osteoporosis and bone density research.