Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65-71 years: a 3-year randomized population-based trial (OSTPRE-FPS).
CONCLUSIONS
The Osteoporosis Risk Factor and Prevention-Fracture Prevention Study (OSTPRE-FPS) was a randomized population-based open trial (n = 593). The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo. Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women.


BACKGROUND
vitamin D deficiency is common in the elderly, and vitamin D levels are associated with low bone mineral density (BMD). The working hypothesis was that vitamin D and calcium supplementation could prevent bone loss in ambulatory postmenopausal women.


METHODS
the OSTPRE-FPS was a randomized population-based open trial with a 3-year follow-up in 3,432 women (aged 66 to 71 years). A randomly selected subsample of 593 subjects underwent BMD measurements. The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo.


RESULTS
in the intention-to-treat analysis, total body BMD (n = 362) increased significantly more in the intervention group than in the control group (0.84% vs. 0.19%, p = 0.011). The BMD change differences at the lumbar spine (p = 0.372), femoral neck (p = 0.188), trochanter (p = 0.085), and total proximal femur (p = 0.070) were statistically nonsignificant. Analyses in compliant women (≥ 80% of use) resulted in stronger and statistically significant effects at the total body and femoral regions.


CONCLUSIONS
daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women with adequate nutritional calcium intake.
Kärkkäinen
M
M
Bone and Cartilage Research Unit, Mediteknia Building, University of Kuopio, P.O. Box 1627, 70211, Kuopio, Finland. Matti.Karkkainen@uku.fi
Tuppurainen
M
M
Salovaara
K
K
Sandini
L
L
Rikkonen
T
T
Sirola
J
J
Honkanen
R
R
Jurvelin
J
J
Alhava
E
E
Kröger
H
H
D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002118:Calcium / Q000009:adverse effects / Q000627:therapeutic use*; D002762:Cholecalciferol / Q000009:adverse effects / Q000627:therapeutic use*; D019587:Dietary Supplements; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015663:Osteoporosis, Postmenopausal / Q000503:physiopathology / Q000517:prevention & control*; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood
D050071:Bone Density Conservation Agents; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D002118:Calcium