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

NCT04003467 | Completed Phase 2

• 1 other identifier: ENT-07-2019
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 4

Brief 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

Osteoporosis

Keywords

Osteoporosis; hPTH(1-34)

Outcome Measures

Primary Outcomes (1)

• Mean % change in P1NP from baseline after 3 months of treatment

  Determine the change in P1NP from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo

  baseline, 3 months

Secondary Outcomes (7)

• Mean % change in BMD (lumbar) from baseline after 6 months of treatment

  baseline, 6 months

• Mean % change in BMD (Femoral Neck and Total Hip) from baseline after 6 months of treatment

  baseline, 6 months

• Mean % change in P1NP from baseline after 6 months of treatment

  baseline, 6 months

• Mean % change in osteocalcin and bone alkaline phosphatase from baseline after 6 months of treatment

  baseline, 6 months

• Mean % change in serum CTX and urine NTX/Creatinine from baseline after 3 months of treatment

  baseline, 3 months

Other Outcomes (3)

• Mean % change in urine cyclic AMP/ creatinine by treatment groups

  6 months

• Correlation between mean urine cyclic AMP/ creatinine at Month 3 and Month 6 and mean % change in P1NP from baseline at Months 3 and 6

  6 months

• Correlation between plasma hPTH(1-34) and urine cyclic AMP/ creatinine at different timepoints

  6 months

Study Arms (5)

EBP05 1.5mg

EXPERIMENTAL

subjects will be randomly assigned to receive 3 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months

Drug: EBP05

Placebo for EBP05 0.5mg (1, 2, 3 or 5)

EXPERIMENTAL

subjects will be randomly assigned to receive 3 or 5 tablets of matching EBP05 placebo orally each day for 6 months

Drug: Placebo of EBP05

EBP05 2.5mg

EXPERIMENTAL

subjects will be randomly assigned to receive 5 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months

Drug: EBP05

EBP05 0.5mg

EXPERIMENTAL

subjects will be randomly assigned to receive 1 tablet of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months

Drug: EBP05

EBP05 1.0mg

EXPERIMENTAL

subjects will be randomly assigned to receive 2 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months

Drug: EBP05

Interventions

EBP05 DRUG

tablets

Also known as: hPTH(1-34), Teriparatide

EBP05 0.5mg; EBP05 1.0mg; EBP05 1.5mg; EBP05 2.5mg

Placebo of EBP05 DRUG

tablets

Also known as: Placebo

Placebo for EBP05 0.5mg (1, 2, 3 or 5)

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: postmenopausal women with low bone mass
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Active gastrointestinal inflammatory disorder, gastrointestinal motility disorders, and chronic gastritis, such as ulcerative colitis, Crohn's disease, irritable bowel syndrome, short bowel syndrome, celiac disease, gastroparesis, etc. that may affect drug bioavailability
• Any conditions or factors that, in the judgment of the Investigator, somehow may impact gastrointestinal absorption, distribution or metabolism of parathyroid hormone analogues, or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease, or surgery (including bariatric surgery) that may affect drug bioavailability
• Acute illness within 14 days of screening
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, that may result in either increased risk or limit her ability to comply with Study Medication administration and scheduled clinical evaluations, as judged by the investigator
• Blood donation (greater than or equal to 500 mL) within 30 days prior to screening
• History of Paget's disease of bone
• History of prior external beam or implant radiation therapy involving the skeleton
• Active urolithiasis
• Primary hyperparathyroidism
• History of alcohol or substance abuse within 3 years prior to screening
• The subject has used an investigational drug within 30 days before the screening visit
• Any past treatment with Forteo®
• History of oncologic disease except for past medical history of a) basal cell or squamous cell skin cancer resected for cure or b) papillary or follicular thyroid cancer localized to the thyroid and resected for cure with no evidence of local or distant recurrence ≥ 5 years after surgery.
• Allergy to soy or known hypersensitivity to PTH

Sponsors & Collaborators

• Entera Bio Ltd.: lead

Study Sites (4)

Hadassah Medical Center, Mt. Scopus Hospital

Jerusalem, 9765422, Israel

Location

Rabin Medical Center, Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 5262160, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Arthur Santora, MD

  Entera Bio Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 1, 2019
• Study Start: June 30, 2019
• Primary Completion: April 27, 2021
• Study Completion: May 11, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)