Osteoporosis (Senile)Phase 2/3NCT07660536
To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study
A Phase 2/3 study testing doxercalciferol capsules, Hectorol® in people with Osteoporosis (Senile), run by Creighton University at 1 site in United States.
Trial summary
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women Read more about this study
- Who is it for?
- Ages 60 to 78 years, women only
- Conditions the study is for
- Osteoporosis (Senile)
- What is being tested?
- doxercalciferol capsules, Hectorol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 1989to 23 Dec 1994
- Phase
- Phase 2/3
- 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 60 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal women, age 60-78 years
- normal general laboratory tests
- serum calcium >10.6 mg/dl (2.65 mmol/L ) or >0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests,
- 24-hour urine calcium < 300mg (7.5mmol) on two baseline tests,
- Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2
Who cannot join
- no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis
- severe chronic illness, chronic renal failure ( serum creatinine >1.4mg/dl ,chronic heart failure,
- any terminal illness
- any history of cancer (except skin cancer) within the last 10 years,
- uncontrolled diabetes with significant proteinuria or fasting blood sugar > 140mg/dl
- alcoholism
Show all 9Show fewer
- prolonged hospitalization , extended immobilizations or arthritis that prevents normal physical activity, hemiplegia, previous hip fracture
- no previous treatment with medication known to affect bone and calcium metabolism within the last year; chronic corticosteroid therapy > 10mg/day thiazides, taking long term bisphosphonates or had them for more than 3 months in the past year, parathyroid hormone or derivatives in the last year, estrogen therapy within the last 6 months, anticonvulsants such as phenytoin ,high dose phenobarbital
- BMI > 45kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical center
Omaha, Nebraska, 68132
About this study
Official title: Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
Read the detailed description
A double blind study of a new type of vitamin D ,named doxercalciferol ( 1α hydroxyvitamin D2) or placebo is given to study its effect on preventing and treating osteoporosis.The trial was a pilot study for one year that was extended to a second year . We used Dual energy Xray absorptiometry (DEXA) to measure bone density of the spine and proximal femur every 6 months.Safety of the drug was monitored by measuring blood and urine calcium frequently.
The study group was post menopausal women.
- Conditions
- Osteoporosis (Senile)
- Being tested
- doxercalciferol capsules, Hectorol®, Matched Placebo (Capsules)
- Keywords
- randomized trial,doxercalciferol,bone density spine and femoral neck,
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxercalciferol capsules, Hectorol®Drug
doxercalciferol capsules given in escalating doses from 1mcg to 5mcg daily.If serum calcium is elevated at any dose then that dose is maintained long term for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months
Matched Placebo (Capsules)Drug
oral doses increased from 1 to 5mcg once daily until serum calcium is elevated and given for 2 years.The change in bone mineral density will be measured at baseline ,12 and 24 months
| Study group | Role | What they receive |
|---|---|---|
| doxercalciferol capsules | Placebo comparator | placebo capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months Receives: Drug: Matched Placebo (Capsules) |
| prevention of osteoporosis | Experimental | doxercalciferol capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months Receives: Drug: doxercalciferol capsules, Hectorol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in spine and femur density over 2 years
measurements every 6 months over 2 years
Measured: Baseline, 6,12,18,24 months at study completion
Secondary outcomes (1)
safety of doxercalciferol on serum and urine calcium excretion
measurement of serum and 24 hour urine calcium
Measured: From enrollment ,measurements at baseline, weeks 1,2,3,4,5,12 after first dose, then every 3 months until study completion at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start14 Nov 1989
- Primary completion22 Apr 1992
- Study completion23 Dec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis (Senile)Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind , placebo control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660536
- Sponsor's protocol ID
- H-102
- Status last verified
- Dec 1992
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: spine, femur density, serum calcium, urine calcium,
Publications
Gallagher JC, Mazess R. Efficacy and safety of doxercalciferol (1alpha hydroxyvitamin D2) on spine and femur bone mineral density in postmenopausal osteopenic women. Front Endocrinol (Lausanne). 2026 Jul 23;17:1640045. doi: 10.3389/fendo.2026.1640045. eCollection 2026.
PubMed 42564695
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women
- ClinicalTrials.gov ID
- NCT07660536
- Acronym / sponsor ID
- H-102
- Conditions
- Osteoporosis (Senile)
- Keywords
- randomized trial,doxercalciferol,bone density spine and femoral neck,
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 14 Nov 1989 (actual)
- Primary completion
- 22 Apr 1992 (actual)
- Study completion
- 23 Dec 1994 (actual)
- First posted
- 22 Jun 2026 (actual)
- 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.
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
Detailed description
A double blind study of a new type of vitamin D ,named doxercalciferol ( 1α hydroxyvitamin D2) or placebo is given to study its effect on preventing and treating osteoporosis.The trial was a pilot study for one year that was extended to a second year . We used Dual energy Xray absorptiometry (DEXA) to measure bone density of the spine and proximal femur every 6 months.Safety of the drug was monitored by measuring blood and urine calcium frequently.
The study group was post menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind , placebo control
| Arm | Type | Receives |
|---|---|---|
| doxercalciferol capsules | Placebo comparator | Drug: Matched Placebo (Capsules)placebo capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months |
| prevention of osteoporosis | Experimental | Drug: doxercalciferol capsules, Hectorol®doxercalciferol capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months |
Who may qualify
- Ages
- 60 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- postmenopausal women, age 60-78 years
- normal general laboratory tests
- serum calcium >10.6 mg/dl (2.65 mmol/L ) or >0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests,
- 24-hour urine calcium < 300mg (7.5mmol) on two baseline tests,
- Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2
Key exclusion criteria (9 listed)
- no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis
- severe chronic illness, chronic renal failure ( serum creatinine >1.4mg/dl ,chronic heart failure,
- any terminal illness
- any history of cancer (except skin cancer) within the last 10 years,
- uncontrolled diabetes with significant proteinuria or fasting blood sugar > 140mg/dl
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 |
|---|---|---|
| doxercalciferol capsules, Hectorol®doxercalciferol capsules given in escalating doses from 1mcg to 5mcg daily.If serum calcium is elevated at any dose then that dose is maintained long term for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months | Drug | prevention of osteoporosis |
| Matched Placebo (Capsules)oral doses increased from 1 to 5mcg once daily until serum calcium is elevated and given for 2 years.The change in bone mineral density will be measured at baseline ,12 and 24 months | Drug | doxercalciferol capsules |
Primary outcome
change in spine and femur density over 2 years
Time frame: Baseline, 6,12,18,24 months at study completion
measurements every 6 months over 2 years
1 secondary outcome
safety of doxercalciferol on serum and urine calcium excretion
Time frame: From enrollment ,measurements at baseline, weeks 1,2,3,4,5,12 after first dose, then every 3 months until study completion at 24 months
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 1 Jul 2026.
- Derived from this study: PubMed 42564695Gallagher JC, Mazess R. Efficacy and safety of doxercalciferol (1alpha hydroxyvitamin D2) on spine and femur bone mineral density in postmenopausal osteopenic women. Front Endocrinol (Lausanne). 2026 Jul 23;17:1640045. doi: 10.3389/fendo.2026.1640045. eCollection 2026.
- Individual participant dataSharing planned: Yes. spine, femur density, serum calcium, urine calcium,
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing doxercalciferol capsules, Hectorol® in people with Osteoporosis (Senile), run by Creighton University at 1 site in United States.
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 5 inclusion and 9 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in spine and femur density over 2 years (time frame: Baseline, 6,12,18,24 months at study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07660536, which also lists 1 linked publication.
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 1 Jul 2026.