Back to resultsStudy to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Primary Purpose
Osteoporosis, Osteopenia
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ZT-034 Low Dose Nasal Spray
ZT-034 Mid Dose Nasal Spray
ZT-034 High Dose Nasal Spray
Teriparatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal Females Age ≥ 45 years.
- Weight > 45 kg and < 90 kg
- Normal nasal examination at baseline.
- Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck
Exclusion Criteria:
- Serious Medical Condition
- History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
- Have a history of cancer within the past 5 years, except for basal cell carcinoma
- Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
- Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Low Dose Nasal Spray
Mid Dose Nasal Spray
High Dose Nasal Spray
Forteo
Placebo Nasal Spray
Arm Description
20ug subcutaneous injection daily
Outcomes
Primary Outcome Measures
Change in Serum P1NP from baseline to end of treatment.
Secondary Outcome Measures
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01604057
Brief Title
Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Official Title
A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azelon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Nasal Spray
Arm Type
Experimental
Arm Title
Mid Dose Nasal Spray
Arm Type
Experimental
Arm Title
High Dose Nasal Spray
Arm Type
Experimental
Arm Title
Forteo
Arm Type
Active Comparator
Arm Description
20ug subcutaneous injection daily
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZT-034 Low Dose Nasal Spray
Intervention Description
Nasal Spray
Intervention Type
Drug
Intervention Name(s)
ZT-034 Mid Dose Nasal Spray
Intervention Description
Nasal Spray
Intervention Type
Drug
Intervention Name(s)
ZT-034 High Dose Nasal Spray
Intervention Description
Nasal Spray
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
20 mcg subcutaneous daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nasal Spray
Primary Outcome Measure Information:
Title
Change in Serum P1NP from baseline to end of treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal Females Age ≥ 45 years.
Weight > 45 kg and < 90 kg
Normal nasal examination at baseline.
Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck
Exclusion Criteria:
Serious Medical Condition
History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
Have a history of cancer within the past 5 years, except for basal cell carcinoma
Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian MacDonald
Organizational Affiliation
Azelon Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
We'll reach out to this number within 24 hrs