Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Azelon Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Azelon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01604057
First received: May 18, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Osteopenia
Drug: ZT-034 Low Dose Nasal Spray
Drug: ZT-034 Mid Dose Nasal Spray
Drug: ZT-034 High Dose Nasal Spray
Drug: Teriparatide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Azelon Pharmaceuticals:

Primary Outcome Measures:
  • Change in Serum P1NP from baseline to end of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: November 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Nasal Spray Drug: ZT-034 Low Dose Nasal Spray
Nasal Spray
Experimental: Mid Dose Nasal Spray Drug: ZT-034 Mid Dose Nasal Spray
Nasal Spray
Experimental: High Dose Nasal Spray Drug: ZT-034 High Dose Nasal Spray
Nasal Spray
Active Comparator: Forteo
20ug subcutaneous injection daily
Drug: Teriparatide
20 mcg subcutaneous daily
Other Name: Forteo
Placebo Comparator: Placebo Nasal Spray Drug: Placebo
Nasal Spray

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604057

Sponsors and Collaborators
Azelon Pharmaceuticals
Investigators
Study Director: Brian MacDonald Azelon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Azelon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01604057     History of Changes
Other Study ID Numbers: ZT-3201
Study First Received: May 18, 2012
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014