Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
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
1 other identifier
interventional
130
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 23, 2012
May 1, 2012
8 months
May 18, 2012
May 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Serum P1NP from baseline to end of treatment.
6 weeks
Secondary Outcomes (1)
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
baseline and 6 weeks
Study Arms (5)
Low Dose Nasal Spray
EXPERIMENTALMid Dose Nasal Spray
EXPERIMENTALHigh Dose Nasal Spray
EXPERIMENTALForteo
ACTIVE COMPARATOR20ug subcutaneous injection daily
Placebo Nasal Spray
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian MacDonald
Azelon Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2012
First Posted
May 23, 2012
Study Start
November 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 23, 2012
Record last verified: 2012-05