Postmenopausal Osteoporosis, Multiple SitesPhase 1NCT01969656
Safety Study of an Oral Vitamin D Analog in Postmenopausal Women
A Phase 1 study testing 2MD and Calcitriol in people with Postmenopausal Osteoporosis, Multiple Sites, run by Deltanoid Pharmaceuticals.
Trial summary
Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Multiple Sites
- What is being tested?
- 2MD and Calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
About this study
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
Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.
- Being tested
- 2MD, Calcitriol, Placebo
- Keywords
- vitamin D analog
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2MDDrug
CalcitriolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Calcitriol | Active comparator | Not described Receives: Drug: Calcitriol |
| 50 ng 2MD | Experimental | Not described Receives: Drug: 2MD |
| 110 ng 2MD | Experimental | Not described Receives: Drug: 2MD |
| 170 ng 2MD | Experimental | Not described Receives: Drug: 2MD |
| 220 ng 2MD | Experimental | Not described Receives: Drug: 2MD |
| 440 ng 2MD | Experimental | Not described Receives: Drug: 2MD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total serum calcium
Measured: 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
Measured: 1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Primary completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Osteoporosis, Multiple SitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
Sponsor and investigators
- Lead sponsor
- Deltanoid Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969656
- Sponsor's protocol ID
- 2MD-3H-1B/C
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2013
- Last updated
- 27 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01969656
- Acronym / sponsor ID
- 2MD-3H-1B/C
- Keywords
- vitamin D analog
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Deltanoid PharmaceuticalsIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2004 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.
Study design
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2MD | Drug | 110 ng 2MD, 170 ng 2MD, 220 ng 2MD, 440 ng 2MD, 50 ng 2MD |
| Calcitriol | Drug | Calcitriol |
| Placebo | Drug | Placebo |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2MD and Calcitriol in people with Postmenopausal Osteoporosis, Multiple Sites, run by Deltanoid Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.