Back to resultsSafety Study of an Oral Vitamin D Analog in Postmenopausal Women
Primary Purpose
Postmenopausal Osteoporosis, Multiple Sites
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
2MD
Calcitriol
Placebo
Sponsored by
About this trial
This is an interventional trial for Postmenopausal Osteoporosis, Multiple Sites focused on measuring vitamin D analog
Eligibility Criteria
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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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Calcitriol
50 ng 2MD
110 ng 2MD
170 ng 2MD
220 ng 2MD
440 ng 2MD
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in total serum calcium
Change from baseline in levels of 2MD in the blood
Secondary Outcome Measures
Full Information
NCT ID
NCT01969656
First Posted
October 22, 2013
Last Updated
July 25, 2017
Sponsor
Deltanoid Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01969656
Brief Title
Safety Study of an Oral Vitamin D Analog in Postmenopausal Women
Official Title
A Phase 1B, Double-Blind, Placebo-Controlled, Calcitriol Active-Controlled, Daily-Dose, Escalating-Dose, Safety and Tolerance Study of 2MD Soft Gel Capsules in Normal Healthy Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deltanoid Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis, Multiple Sites
Keywords
vitamin D analog
7. Study Design
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Calcitriol
Arm Type
Active Comparator
Arm Title
50 ng 2MD
Arm Type
Experimental
Arm Title
110 ng 2MD
Arm Type
Experimental
Arm Title
170 ng 2MD
Arm Type
Experimental
Arm Title
220 ng 2MD
Arm Type
Experimental
Arm Title
440 ng 2MD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
2MD
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in total serum calcium
Time Frame
Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose
Title
Change from baseline in levels of 2MD in the blood
Time Frame
1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
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.
-
12. IPD Sharing Statement
Learn more about this trial
Safety Study of an Oral Vitamin D Analog in Postmenopausal Women
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