Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

Launched by NASTECH PHARMACEUTICAL COMPANY, INC. · Feb 26, 2008

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Postmenopausal Female patients up to 89 years, inclusive;
• • BMI ≤ 35 kg/m2, inclusive;
• • In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
• • Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
• • Have a minimum of two evaluable non-fractured lumbar vertebrae.
• • Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip
• 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.