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

NCT ID: NCT01604057

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-07-31

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.

Conditions

Osteoporosis; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Dose Nasal Spray

Group Type: EXPERIMENTAL

ZT-034 Low Dose Nasal Spray

Intervention Type: DRUG

Nasal Spray

Mid Dose Nasal Spray

Group Type: EXPERIMENTAL

ZT-034 Mid Dose Nasal Spray

Intervention Type: DRUG

Nasal Spray

High Dose Nasal Spray

Group Type: EXPERIMENTAL

ZT-034 High Dose Nasal Spray

Intervention Type: DRUG

Nasal Spray

Forteo

20ug subcutaneous injection daily

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

20 mcg subcutaneous daily

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Nasal Spray

Interventions

ZT-034 Low Dose Nasal Spray

Nasal Spray

Intervention Type: DRUG

ZT-034 Mid Dose Nasal Spray

Nasal Spray

Intervention Type: DRUG

ZT-034 High Dose Nasal Spray

Nasal Spray

Intervention Type: DRUG

Teriparatide

20 mcg subcutaneous daily

Intervention Type: DRUG

Placebo

Nasal Spray

Intervention Type: DRUG

Other Intervention Names

Forteo

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azelon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian MacDonald

Role: STUDY_DIRECTOR

Azelon Pharmaceuticals

Other Identifiers

ZT-3201

Identifier Type: -

Identifier Source: org_study_id