Safety Study of an Oral Vitamin D Analog in Postmenopausal Women
NCT ID: NCT01969656
Last Updated: 2017-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Placebo
Placebo
Calcitriol
Calcitriol
50 ng 2MD
2MD
110 ng 2MD
2MD
170 ng 2MD
2MD
220 ng 2MD
2MD
440 ng 2MD
2MD
Interventions
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2MD
Calcitriol
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Within ±30% of their ideal body weight for height and body frame.
3. Demonstrated ability to understand and willingness to sign an Informed Consent Form.
4. 24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
5. Negative urine test for selected drugs of abuse.
6. Willing to maintain a total calcium intake between 700 and 1000 mg/day.
Exclusion Criteria
2. Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
3. History or presence of any diseases known or believed to influence calcium absorption or metabolism.
4. History of renal calculi.
5. History of an eating disorder.
6. History of stomach or intestinal surgery.
7. History of hypersensitivity or allergies to any vitamin D derivative.
8. History or presence of an abnormal ECG.
9. Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
10. Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
11. Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
12. Use of vitamin and/or mineral supplements \>1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
13. Poor peripheral venous access.
14. Receipt of blood products within 2 months prior to study entry.
\-
45 Years
80 Years
FEMALE
No
Sponsors
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Deltanoid Pharmaceuticals
INDUSTRY
Responsible Party
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Other Identifiers
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2MD-3H-1B/C
Identifier Type: -
Identifier Source: org_study_id
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