Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-02 @ 7:05 AM
Study NCT ID:
NCT04003467
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
Sponsor:
Entera Bio Ltd.
Organization:
Study Overview
Official Title:
A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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.
The screening phase to evaluate subject eligibility may start 56 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 should be sent to the central reading vendor at least 10 days prior to scheduled potential Day 1 in order to allow timely turnaround of results. The site will receive unblinded results.
A DXA BMD scan performed for medical care unrelated to the study may be used as the screening BMD if obtained no more than 14 days prior the start of screening and performed with the same scanner which was qualified for the study and according to the study specific guidelines and procedures referenced in section 8.1.2. If the subject is eligible for randomization, the DXA scan does not have to be repeated unless there is a delay in the start of Study Medication beyond the 28-day Screening period (see 4.4.3, Extension of Screening window).
Protocol Version 3.0 describes the randomization of the first 103 subjects. In Protocol version 4.0, after completion of all screening procedures eligible subjects will come for the first visit and will be randomized to one of three treatment arms (EBP05 1.5 mg, 2.5 mg or placebo). A randomized allocation schedule will allocate 6 to EBP05 1.5 mg, 36 to 2.5 mg and 18 to placebo.
In Protocol Version 5.0 the starting dose of EBP05 for subjects randomized into the EBP05 2.5 mg treatment group was changed to 1.5 mg (3 tablets). Subjects randomized to Placebo and assigned to the 5 placebo tablet group will also be started on 3 tablets. At the Month 1 visit, the starting dose will be increased to 4 tablets of EPB05 (2.0 mg) or placebo if no continuing drug-related AEs (as assessed by the Investiagor) are present. At Month 2 the dose will be increased to 5 tablets of EPB05 (2.5 mg) or placebo if no continuing drug-related AEs are present. If symptoms associated with administration of Study Medication occur with a dose increase, the dose should be decreased to 3 tablets daily (1.5 mg). Subjects who tolerate the highest dose (5 tablets ,2.5 mg) without drug-related sympoms will continue on that dose for the remainder of the study. Subjects who do not tolerate a dose increase (either 3 tablets to 4 tablets or 4 tablets to 5 tablets) will have their dose reduced to 3 tablets (1.5 mg) daily.
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 sent 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.
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.
The screening phase to evaluate subject eligibility may start 56 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 should be sent to the central reading vendor at least 10 days prior to scheduled potential Day 1 in order to allow timely turnaround of results. The site will receive unblinded results.
A DXA BMD scan performed for medical care unrelated to the study may be used as the screening BMD if obtained no more than 14 days prior the start of screening and performed with the same scanner which was qualified for the study and according to the study specific guidelines and procedures referenced in section 8.1.2. If the subject is eligible for randomization, the DXA scan does not have to be repeated unless there is a delay in the start of Study Medication beyond the 28-day Screening period (see 4.4.3, Extension of Screening window).
Protocol Version 3.0 describes the randomization of the first 103 subjects. In Protocol version 4.0, after completion of all screening procedures eligible subjects will come for the first visit and will be randomized to one of three treatment arms (EBP05 1.5 mg, 2.5 mg or placebo). A randomized allocation schedule will allocate 6 to EBP05 1.5 mg, 36 to 2.5 mg and 18 to placebo.
In Protocol Version 5.0 the starting dose of EBP05 for subjects randomized into the EBP05 2.5 mg treatment group was changed to 1.5 mg (3 tablets). Subjects randomized to Placebo and assigned to the 5 placebo tablet group will also be started on 3 tablets. At the Month 1 visit, the starting dose will be increased to 4 tablets of EPB05 (2.0 mg) or placebo if no continuing drug-related AEs (as assessed by the Investiagor) are present. At Month 2 the dose will be increased to 5 tablets of EPB05 (2.5 mg) or placebo if no continuing drug-related AEs are present. If symptoms associated with administration of Study Medication occur with a dose increase, the dose should be decreased to 3 tablets daily (1.5 mg). Subjects who tolerate the highest dose (5 tablets ,2.5 mg) without drug-related sympoms will continue on that dose for the remainder of the study. Subjects who do not tolerate a dose increase (either 3 tablets to 4 tablets or 4 tablets to 5 tablets) will have their dose reduced to 3 tablets (1.5 mg) daily.
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 sent 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: