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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

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ClinicalTrials.gov Identifier: NCT01604057
Recruitment Status : Unknown
Verified May 2012 by Azelon Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Azelon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 18, 2012
First Posted Date  ICMJE May 23, 2012
Last Update Posted Date May 23, 2012
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
Change in Serum P1NP from baseline to end of treatment. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) [ Time Frame: baseline and 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Osteopenia
Intervention  ICMJE
  • Drug: ZT-034 Low Dose Nasal Spray
    Nasal Spray
  • Drug: ZT-034 Mid Dose Nasal Spray
    Nasal Spray
  • Drug: ZT-034 High Dose Nasal Spray
    Nasal Spray
  • Drug: Teriparatide
    20 mcg subcutaneous daily
    Other Name: Forteo
  • Drug: Placebo
    Nasal Spray
Study Arms  ICMJE
  • Experimental: Low Dose Nasal Spray
    Intervention: Drug: ZT-034 Low Dose Nasal Spray
  • Experimental: Mid Dose Nasal Spray
    Intervention: Drug: ZT-034 Mid Dose Nasal Spray
  • Experimental: High Dose Nasal Spray
    Intervention: Drug: ZT-034 High Dose Nasal Spray
  • Active Comparator: Forteo
    20ug subcutaneous injection daily
    Intervention: Drug: Teriparatide
  • Placebo Comparator: Placebo Nasal Spray
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 21, 2012)
130
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604057
Other Study ID Numbers  ICMJE ZT-3201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Azelon Pharmaceuticals
Study Sponsor  ICMJE Azelon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian MacDonald Azelon Pharmaceuticals
PRS Account Azelon Pharmaceuticals
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP