Safety Study of an Oral Vitamin D Analog in Postmenopausa... | NCT01969656

Studies
Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

NCT01969656

Sponsor

Deltanoid Pharmaceuticals

Status

Completed

Last Update Posted

Jul 27, 2017Actual

Enrollment

Not provided

Phase

Phase 1

Conditions

Postmenopausal Osteoporosis, Multiple Sites

Interventions

2MD
Calcitriol
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Jun 2004Actual

Completion Date

Not provided

First Submitted Date

Oct 22, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 27, 2017Actual

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
2MD	Drug		110 ng 2MD 170 ng 2MD 220 ng 2MD 440 ng 2MD 50 ng 2MD
Calcitriol

Measure	Description	Time Frame
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

Eligibility Module

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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Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D004100	Dihydroxycholecalciferols
D006887	Hydroxycholecalciferols
D002762	Cholecalciferol
D002782	Cholestenes