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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 19, 2013