Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

NCT01969656 | Completed Phase 1

• 1 other identifier: 2MD-3H-1B/C
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postmenopausal Osteoporosis, Multiple Sites

Keywords

vitamin D analog

Outcome Measures

Primary Outcomes (2)

• Change from baseline in total serum calcium

  Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose

• Change from baseline in levels of 2MD in the blood

  1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Calcitriol

ACTIVE COMPARATOR

Drug: Calcitriol

50 ng 2MD

EXPERIMENTAL

Drug: 2MD

110 ng 2MD

EXPERIMENTAL

Drug: 2MD

170 ng 2MD

EXPERIMENTAL

Drug: 2MD

220 ng 2MD

EXPERIMENTAL

Drug: 2MD

440 ng 2MD

EXPERIMENTAL

Drug: 2MD

Interventions

2MD DRUG

110 ng 2MD; 170 ng 2MD; 220 ng 2MD; 440 ng 2MD; 50 ng 2MD

Calcitriol DRUG

Calcitriol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deltanoid Pharmaceuticals: lead

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Primary Completion: June 1, 2004
• Last Updated: July 27, 2017

Record last verified: 2017-07