A Phase 3 interventional study of calcium supplementation and calcium and vitamin D3 supplementation in Osteoporosis and Secondary Hyperparathyroidism, sponsored by Creighton University. Completed. Open to female participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-11.
Sponsored by Creighton University · Phase 3, Interventional, and Treatment
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.
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.
1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.
This study's enrollment of 1,180 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Creighton University is the lead sponsor of 127 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: healthy women ages 55 and older who were at least four years postmenopausal living independently in a nine-county rural area of Nebraska
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Exclusion Criteria:
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
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calcium supplementation
Dietary Supplement: calcium supplementation
calcium and vitamin D3 supplementation
Dietary Supplement: calcium and vitamin D3 supplementation
placebo
Dietary Supplement: Placebo
calcium carbonate 1500 mg/day
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
calcium and vitamin D3 placebo
fractures
Time frame: 4 years
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
No study locations are listed for this record.
The record gives a start of May 2000, a primary completion of Jul 2005 and a completion of Jul 2005. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium