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Trial record 43 of 165 for:    Recruiting, Not yet recruiting, Available Studies | Osteoporosis

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

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ClinicalTrials.gov Identifier: NCT04003467
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Entera Bio Ltd.

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 -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) over 50 years of age will receive Study Medication. The treatment phase will consist of 4 different treatment arms, with approximately 40 subjects per treatment arm. The treatments arms are:

Oral EBP05 0.5mg x1 tablet (total dose 0.5mg), Oral EBP05 0.5mg x2 tablets (1mg), Oral EBP05 0.5mg x3 tablets (1.5mg), Oral Placebo for EBP05 0.5mg (split to sub-groups of: 1,2, or 3 tablets).


Condition or disease Intervention/treatment Phase
Osteoporosis Drug: EBP05 Drug: Placebo of EBP05 Phase 2

Detailed Description:

The screening phase to evaluate subject eligibility may start 28 days prior to the treatment phase. BMD screening (DXA scan) will be performed locally on approved vendors standardized machines and interpreted locally. If a subject is found to be suitable, the BMD results will be sent for central reading. The screening DXA scan must be sent to the central reading vendor at least 7 days prior to scheduled potential Day 1 in order to allow timely turnaround of results. The site will receive unblinded results.

After completion of all screening procedures, eligible subjects will come for the first visit and will be randomized to one of the four treatment arms with up to 40 subjects per treatment arm.

Subjects will receive Study Medication and education on Study Medication intake.

Subjects will visit the clinic once a month for the first three months, and at 6 months for the end of treatment or at any time in-between for an Early Termination Visit, if applicable. There will be telephone calls at Week 2, Month 4 and Month 5 for a general compliance/safety check. The final follow-up visit will also be conducted by phone.

The 6-month DXA scan will be send for central reading. Unblinded results will not be released to the sites prior to Data Base Lock.

At the End of Treatment visit, concomitant medications will be reviewed, and outcome of AEs recorded, if applicable. The subjects must return all used Study Medication containers. Unused medication should also be returned, collected and accounted for.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EBP05 0.5mg
40 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
tablets
Other Names:
  • hPTH(1-34)
  • Teriparatide

Experimental: EBP05 1mg
40 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
tablets
Other Names:
  • hPTH(1-34)
  • Teriparatide

Experimental: EBP05 1.5mg
40 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
tablets
Other Names:
  • hPTH(1-34)
  • Teriparatide

Experimental: Placebo for EBP05 0.5mg (1, 2 or 3)
40 subjects will be randomly assigned to receive 1, 2 or 3 tablets of matching EBP05 placebo containing 0.5mg, 1 mg or 1.5 mg hPTH(1-34) orally each day for 6 months
Drug: Placebo of EBP05
tablets
Other Name: Placebo




Primary Outcome Measures :
  1. Mean % change in P1NP from baseline after 3 months of treatment [ Time Frame: baseline, 3 months ]
    Determine the change in P1NP from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo


Secondary Outcome Measures :
  1. Mean % change in BMD (lumbar) from baseline after 6 months of treatment [ Time Frame: baseline, 6 months ]
    Determine the change in BMD (lumbar spine) from Baseline at Month 6 compared with the change during treatment with placebo

  2. Mean % change in BMD (Femoral Neck and Total Hip) from baseline after 6 months of treatment [ Time Frame: baseline, 6 months ]
    Determine the change in BMD (Femoral Neck and Total Hip) from Baseline at Month 6 compared with the change during treatment with placebo.

  3. Mean % change in P1NP from baseline after 6 months of treatment [ Time Frame: baseline, 6 months ]
    Determine the change in P1NP from baseline during treatment with oral EBP05 for 6 months compared with the change during treatment with placebo.

  4. Mean % change in osteocalcin and bone alkaline phosphatase from baseline after 6 months of treatment [ Time Frame: baseline, 6 months ]
    Determine the changes in osteocalcin and bone alkaline phosphatase from baseline during treatment with oral EBP05 for 3 and 6 months compared with the change during treatment with placebo.

  5. Mean % change in serum CTX and urine NTX/Creatinine from baseline after 3 months of treatment [ Time Frame: baseline, 3 months ]
    Determine the change in serum CTX and urine NTX/Creatinine from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo.

  6. Mean % change in serum CTX and urine NTX/Creatinine from baseline after 6 months of treatment Change of BMD (lumbar) after 6 months of treatment [ Time Frame: baseline, 6 months ]
    Determine the changes in serum CTX and urine NTX/Creatinine from baseline during treatment with oral EBP05 for 6 months compared with the change during treatment with placebo.

  7. Concentration of plasma hPTH(1-34) 15 min after Study Medication administration [ Time Frame: 6 months ]
    Provide descriptive statistics of plasma hPTH(1-34) concentration 15 min. after Study Medication administration at Day 1, Month 1, Month 3 and Month 6 by treatment group


Other Outcome Measures:
  1. Mean % change in urine cyclic AMP/ creatinine by treatment groups [ Time Frame: 6 months ]
    Determine the effect of treatment with EBP05 and placebo on urine cyclic AMP/ creatinine (total urine collected over 1.5-hour post dose) on Day 1, Month 1, Month 3 and Month 6 as a pharmacodynamic response to EPB05

  2. 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 [ Time Frame: 6 months ]
    Evaluate the correlation between urine cyclic AMP/ creatinine (total urine collected over 1.5-hour post dose) at Month 3 and Month 6 and P1NP change from baseline at Months 3 and 6

  3. Correlation between plasma hPTH(1-34) and urine cyclic AMP/ creatinine at different timepoints [ Time Frame: 6 months ]
    Evaluate the correlation between plasma hPTH(1-34) 15 minutes after oral administration of EBP05 and urine cyclic AMP/ creatinine (total urine collected over 1.5-hour post dose).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   postmenopausal women with low bone mass
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female subjects above 50 years of age
  2. Body Mass Index (BMI) between ≥18.5 and ≤35 kg/m2
  3. Signed Informed Consent Form
  4. Able to adhere to the visit schedule and protocol requirements
  5. At least 3 years post menopause (physiological or surgical)
  6. Women who are less than 55 years old need to have estradiol and LH in the menopausal range
  7. Low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)

    Exclusion Criteria:

  8. 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
  9. 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
  10. History of significant gastrointestinal, liver or kidney disease, or surgery (including bariatric surgery) that may affect drug bioavailability
  11. Acute illness within 14 days of screening
  12. 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
  13. Blood donation (greater than or equal to 500 mL) within 30 days prior to screening
  14. History of Paget's disease of bone
  15. History of prior external beam or implant radiation therapy involving the skeleton
  16. Active urolithiasis
  17. Primary hyperparathyroidism
  18. History of alcohol or substance abuse within 3 years prior to screening
  19. The subject has used an investigational drug within 30 days before the screening visit
  20. Any past treatment with Forteo®
  21. History of oncologic disease except for past medical history of basal cell or squamous cell skin cancer resected for cure
  22. Allergy to soy or known hypersensitivity to PTH
  23. Known allergies or sensitivities to components of the Study Medication
  24. Abnormal calcium, magnesium, phosphate or alkaline phosphatase (outside of lab reference ranges) on screening visit
  25. Significant renal impairment (eGFR <45mL/min/1.73 m2 as measured by MDRD)
  26. Any other clinically significant abnormal biochemistry, hematology or urinalysis at screening that are not explained by a disease recorded in the subject's medical history, as judged by the investigator
  27. Chronic morning medication that cannot be taken at least 1-hr post-Study Medication dose
  28. Any osteoporosis treatment within the last 2 years.
  29. Any use of fluoride (dose greater than 1 mg/day) or strontium ranelate
  30. Any use of intravenous bisphosphonate in the last 10 years.
  31. Any use of denosumab within the last 3 years
  32. Any oral bisphosphonate use for more than 6 months (or Risedronate for over 1 year) in the last 5 years.
  33. Any oral bisphosphonate use for more than 3 years (or Risedronate for over 5 years) ending in the last 10 years.
  34. Systemic glucocorticoids (current use: ≥ 2.5 mg prednisone or equivalent), or prior use ≥ 5 mg per day for more than 1 week in the last year
  35. Hyperthyroidism or hypothyroidism not treated with thyroxine replacement to achieve normal TSH
  36. Serious medical conditions currently under evaluation or treatment
  37. Disorders of bone and mineral metabolism other than osteoporosis, including Vitamin D deficiency that has not been treated with Vitamin D ≥ 1000 IU for at least 6 months.
  38. Severe osteoporosis defined as a BMD below -3.5 or previous osteoporotic (low-energy trauma) fractures (precluding use of placebo)
  39. The Investigator should exclude subjects at his own judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003467


Locations
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Israel
Hadassah Medical Center, Mt. Scopus Hospital Recruiting
Jerusalem, Israel, 9765422
Contact: Auryan Szalat, MD    02-5845384    auryans@hadassah.org.il   
Principal Investigator: Auryan Szalat, MD         
Rabin Medical Center, Beilinson Campus Recruiting
Petach Tikva, Israel, 4941492
Contact: Gloria Tsvetov, MD    03-9376997    gloriats@clalit.org.il   
Principal Investigator: Gloria Tsvetov, MD         
Sheba Medical Center Recruiting
Ramat-Gan, Israel, 5262160
Contact: Liana Tripto-Shkolnik, MD    03-5305475    Triptoshkolnik.liana@sheba.health.gov.il   
Principal Investigator: Liana Tripto-Shkolnik, MD         
Tel-Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Contact: Vanessa Rouach, MD    03-6974243    v.rouach@gmail.com   
Principal Investigator: Vanessa Rouach, MD         
Sponsors and Collaborators
Entera Bio Ltd.
Investigators
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Study Director: Arthur Santora, MD Entera Bio Ltd.

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Responsible Party: Entera Bio Ltd.
ClinicalTrials.gov Identifier: NCT04003467     History of Changes
Other Study ID Numbers: ENT-07-2019
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Entera Bio Ltd.:
Osteoporosis
hPTH(1-34)

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents