NCT01604057UnknownPhase 2
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
Azelon Pharmaceuticals0 sites130 target enrollmentStarted: November 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 130
- Primary Endpoint
- Change in Serum P1NP from baseline to end of treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low Dose Nasal Spray
Experimental
Intervention: ZT-034 Low Dose Nasal Spray (Drug)
Mid Dose Nasal Spray
Experimental
Intervention: ZT-034 Mid Dose Nasal Spray (Drug)
High Dose Nasal Spray
Experimental
Intervention: ZT-034 High Dose Nasal Spray (Drug)
Forteo
Active Comparator
20ug subcutaneous injection daily
Intervention: Teriparatide (Drug)
Placebo Nasal Spray
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Serum P1NP from baseline to end of treatment.
Time Frame: 6 weeks
Secondary Outcomes
- Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)(baseline and 6 weeks)
Investigators
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