OsteoporosisPhase 3NCT00357643
Effect of Calcium and Vitamin D on Bone Loss From the Hip
A Phase 3 study testing Calcium 500 mg/day and vitamin D 700 IU/day in people with Osteoporosis, run by Tufts University at 1 site in United States.
Trial summary
The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Calcium 500 mg/day and vitamin D 700 IU/day
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1992to Feb 1996
- Phase
- Phase 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- >65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment
Who cannot join
- Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition Research Center on Aging at Tufts U
Boston, Massachusetts, 02111
About this study
The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.
Read the detailed description
In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.
- Conditions
- Osteoporosis
- Being tested
- Calcium 500 mg/day and vitamin D 700 IU/day
- Keywords
- calcium, vitamin D, bone loss
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium 500 mg/day and vitamin D 700 IU/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density of the hip
Secondary outcomes (3)
Annual and Seasonal patterns of change in bone mineral density of the hip
Associations between biochemical, physical and life-style factors
Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startOct 1992
- Study completionFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Bess Dawson-Hughes, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357643
- Sponsor's protocol ID
- U01AG010353
- Status last verified
- Jun 2005
- First submitted
- 26 Jul 2006
- Last updated
- 27 Jul 2006
- Results posted
- No
Publications
Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. doi: 10.1056/NEJM199709043371003.
PubMed 9278463Dawson-Hughes B, Harris SS, Ceglia L, Palermo NJ. Serum sclerostin levels vary with season. J Clin Endocrinol Metab. 2014 Jan;99(1):E149-52. doi: 10.1210/jc.2013-3148. Epub 2013 Dec 20.
PubMed 24248178Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
PubMed 17277040
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium and Vitamin D on Bone Loss From the Hip
- ClinicalTrials.gov ID
- NCT00357643
- Acronym / sponsor ID
- U01AG010353
- Conditions
- Osteoporosis
- Keywords
- calcium, vitamin D, bone loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 1992
- Study completion
- Feb 1996
- First posted
- 27 Jul 2006 (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.
The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.
Detailed description
In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- >65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment
Key exclusion criteria (1 listed)
- Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.
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 |
|---|---|---|
| Calcium 500 mg/day and vitamin D 700 IU/day | Drug | – |
Primary outcome
Bone Density of the hip
3 secondary outcomes
Annual and Seasonal patterns of change in bone mineral density of the hip
Associations between biochemical, physical and life-style factors
Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls
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 2006.
- Results publication: PubMed 9278463Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. doi: 10.1056/NEJM199709043371003.
- Derived from this study: PubMed 24248178Dawson-Hughes B, Harris SS, Ceglia L, Palermo NJ. Serum sclerostin levels vary with season. J Clin Endocrinol Metab. 2014 Jan;99(1):E149-52. doi: 10.1210/jc.2013-3148. Epub 2013 Dec 20.
- Derived from this study: PubMed 17277040Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
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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.
Bess Dawson-Hughes, MD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium 500 mg/day and vitamin D 700 IU/day in people with Osteoporosis, run by Tufts 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 1 inclusion and 1 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 2006. 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. 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 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?
Bone Density of the hip. 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 NCT00357643, which also lists 3 linked publications.
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 2006.