OsteoporosisPhase 3NCT00352170
Calcium and Vitamin D Malnutrition in Elderly Women
A Phase 3 study testing calcium supplementation and calcium and vitamin D3 supplementation in people with Osteoporosis and Secondary Hyperparathyroidism, run by Creighton University.
Trial summary
This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Secondary Hyperparathyroidism
- What is being tested?
- calcium supplementation and calcium and vitamin D3 supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,180 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jul 2005
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and
- -
About this study
This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.
- A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
- A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.
Read the detailed description
We are conducting a 4-year randomized, double-blind, placebo controlled trial of calcium or calcium with vitamin D supplementation. We randomly sampled the population of healthy, independent living women 55+ years in nine rural counties. We randomly assigned 1180 women to one of three groups: Group 1 receives calcium (1400 mg/d) and vitamin D placebo, Group 2 receives both calcium (1400 mg/d) and vitamin D (1100 IU/d) and Group 3 receives both placebos.
A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area. The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation. The participants were enrolled into study between May 2000 and July 2001.
Participants have study visits every six months. Annually the following are performed: bone density scans, height and weight, brief medical history including medicine changes, fracture surveillance, and compliance with calcium and vitamin D. At baseline and end of study, spine x-rays and dietary recall were obtained.
- Conditions
- Osteoporosis, Secondary Hyperparathyroidism
- Being tested
- calcium supplementation, calcium and vitamin D3 supplementation, Placebo
- Keywords
- calcium, vitamin D, secondary hyperparathyroidism, osteoporotic fractures
- Medical subject headings
- Osteoporosis, Hyperparathyroidism, Secondary, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium supplementationDietary supplement
calcium carbonate 1500 mg/day
calcium and vitamin D3 supplementationDietary supplement
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
PlaceboDietary supplement
calcium and vitamin D3 placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | calcium supplementation Receives: Dietary Supplement: calcium supplementation |
| 2 | Experimental | calcium and vitamin D3 supplementation Receives: Dietary Supplement: calcium and vitamin D3 supplementation |
| 3 | Experimental | placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractures
Measured: 4 years
Secondary outcomes (5)
changes in bone mass and density
Measured: 4 years
changes in serum dihydroxyvitamin D
Measured: one year and four years
changes in serum parathyroid hormone
Measured: one year and four years
cancer
Measured: four years
Falls
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startMay 2000
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Joan M Lappe, Ph.D, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352170
- Sponsor's protocol ID
- Ag14683
- Status last verified
- Aug 2008
- First submitted
- 12 Jul 2006
- Last updated
- 11 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. doi: 10.1093/ajcn/85.6.1586.
PubMed 17556697Zhou Y, Zhao LJ, Xu X, Ye A, Travers-Gustafson D, Zhou B, Wang HW, Zhang W, Lee Hamm L, Deng HW, Recker RR, Lappe JM. DNA methylation levels of CYP2R1 and CYP24A1 predict vitamin D response variation. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:207-14. doi: 10.1016/j.jsbmb.2013.10.004. Epub 2013 Oct 12.
PubMed 24128439
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium and Vitamin D Malnutrition in Elderly Women
- ClinicalTrials.gov ID
- NCT00352170
- Acronym / sponsor ID
- Ag14683
- Conditions
- Osteoporosis, Secondary Hyperparathyroidism
- Keywords
- calcium, vitamin D, secondary hyperparathyroidism, osteoporotic fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2000
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 14 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.
This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.
- A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
- A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.
Detailed description
We are conducting a 4-year randomized, double-blind, placebo controlled trial of calcium or calcium with vitamin D supplementation. We randomly sampled the population of healthy, independent living women 55+ years in nine rural counties. We randomly assigned 1180 women to one of three groups: Group 1 receives calcium (1400 mg/d) and vitamin D placebo, Group 2 receives both calcium (1400 mg/d) and vitamin D (1100 IU/d) and Group 3 receives both placebos.
A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area. The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation. The participants were enrolled into study between May 2000 and July 2001.
Participants have study visits every six months. Annually the following are performed: bone density scans, height and weight, brief medical history including medicine changes, fracture surveillance, and compliance with calcium and vitamin D. At baseline and end of study, spine x-rays and dietary recall were obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: calcium supplementationcalcium supplementation |
| 2 | Experimental | Dietary Supplement: calcium and vitamin D3 supplementationcalcium and vitamin D3 supplementation |
| 3 | Experimental | Dietary Supplement: Placeboplacebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and
- -
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 supplementationcalcium carbonate 1500 mg/day | Dietary supplement | 1 |
| calcium and vitamin D3 supplementationcalcium carbonate 1500 mg/day vitamin D3 1000 IU/day | Dietary supplement | 2 |
| Placebocalcium and vitamin D3 placebo | Dietary supplement | 3 |
Primary outcome
fractures
Time frame: 4 years
5 secondary outcomes
changes in bone mass and density
Time frame: 4 years
changes in serum dihydroxyvitamin D
Time frame: one year and four years
changes in serum parathyroid hormone
Time frame: one year and four years
cancer
Time frame: four years
Falls
Time frame: four years
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 11 Aug 2008.
- Results publication: PubMed 17556697Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. doi: 10.1093/ajcn/85.6.1586.
- Derived from this study: PubMed 24128439Zhou Y, Zhao LJ, Xu X, Ye A, Travers-Gustafson D, Zhou B, Wang HW, Zhang W, Lee Hamm L, Deng HW, Recker RR, Lappe JM. DNA methylation levels of CYP2R1 and CYP24A1 predict vitamin D response variation. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:207-14. doi: 10.1016/j.jsbmb.2013.10.004. Epub 2013 Oct 12.
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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.
Joan M Lappe, Ph.D principal investigator
Creighton University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing calcium supplementation and calcium and vitamin D3 supplementation in people with Osteoporosis and Secondary Hyperparathyroidism, run by Creighton University.
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 0 inclusion and 2 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 11 Aug 2008. 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. 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?
fractures (time frame: 4 years). 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 NCT00352170, which also lists 2 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 11 Aug 2008.