Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Deltanoid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Osteoporosis, Multiple Sites

Treatments: Drug: Placebo; Drug: 2MD; Drug: Calcitriol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969656

2MD-3H-1B/C

Details and patient eligibility

About

Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.

Sex: Female

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
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

1. Any acute or chronic condition that would limit the subject's ability to complete the study.

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.

Trial design

0 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Calcitriol

Active Comparator group

Treatment:

Drug: Calcitriol

50 ng 2MD

Experimental group

Treatment:

Drug: 2MD

110 ng 2MD

Experimental group

Treatment:

Drug: 2MD

170 ng 2MD

Experimental group

Treatment:

Drug: 2MD

220 ng 2MD

Experimental group

Treatment:

Drug: 2MD

440 ng 2MD

Experimental group

Treatment:

Drug: 2MD