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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

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Serum P1NP from baseline to end of treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) [ Time Frame: baseline and 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604057


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

Responsible Party: Azelon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01604057     History of Changes
Other Study ID Numbers: ZT-3201
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

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