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

Azelon Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Osteopenia; Osteoporosis

Treatments: Drug: Teriparatide; Drug: ZT-034 High Dose Nasal Spray; Drug: ZT-034 Mid Dose Nasal Spray; Drug: Placebo; Drug: ZT-034 Low Dose Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT01604057

ZT-3201

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 5 patient groups, including a placebo group

Low Dose Nasal Spray

Experimental group

Treatment:

Drug: ZT-034 Low Dose Nasal Spray

Mid Dose Nasal Spray

Experimental group

Treatment:

Drug: ZT-034 Mid Dose Nasal Spray

High Dose Nasal Spray

Experimental group

Treatment:

Drug: ZT-034 High Dose Nasal Spray

Forteo

Active Comparator group

Description:

20ug subcutaneous injection daily

Treatment:

Drug: Teriparatide

Placebo Nasal Spray

Placebo Comparator group

Treatment:

Drug: Placebo