Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Inclusion criteria

• Normal healthy postmenopausal women, ≥ 60 but ≤ 80 years of age, or between 45 and 60 years of age who have been amenorrheic for at least 2 years plus have a serum FSH level of > 30 IU/L, or women with a documented bilateral oophorectomy at least 2 years prior to study start.
• Within ±30% of their ideal body weight for height and body frame.
• Demonstrated ability to understand and willingness to sign an Informed Consent Form.
• 24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
• Negative urine test for selected drugs of abuse.
• Willing to maintain a total calcium intake between 700 and 1000 mg/day.

Exclusion criteria

• Any acute or chronic condition that would limit the subject's ability to complete the study.
• Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
• History or presence of any diseases known or believed to influence calcium absorption or metabolism.
• History of renal calculi.
• History of an eating disorder.
• History of stomach or intestinal surgery.
• History of hypersensitivity or allergies to any vitamin D derivative.
• History or presence of an abnormal ECG.
• Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
• Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
• Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
• Use of vitamin and/or mineral supplements >1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
• Poor peripheral venous access.
• Receipt of blood products within 2 months prior to study entry.

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