Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
This trial is active, not recruiting.
|Treatments||zt-034 low dose nasal spray, zt-034 mid dose nasal spray, zt-034 high dose nasal spray, teriparatide, placebo|
|Start date||November 2011|
|End date||July 2012|
|Trial size||130 participants|
|Trial identifier||NCT01604057, ZT-3201|
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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in Serum P1NP from baseline to end of treatment.
time frame: 6 weeks
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
time frame: baseline and 6 weeks
Female participants at least 45 years old.
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
|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|
Call for more information