Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Information source: Azelon Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis; Osteopenia
Intervention: ZT-034 Low Dose Nasal Spray (Drug); ZT-034 Mid Dose Nasal Spray (Drug); ZT-034 High Dose Nasal Spray (Drug); Teriparatide (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Azelon Pharmaceuticals Official(s) and/or principal investigator(s):
Brian MacDonald, Study Director, Affiliation: Azelon Pharmaceuticals
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Serum P1NP from baseline to end of treatment.
Secondary outcome: Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: November 2011
Last updated: May 21, 2012
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