PMID- 21521859
OWN - NLM
STAT- MEDLINE
DCOM- 20110915
LR  - 20180813
IS  - 1542-6270 (Electronic)
IS  - 1060-0280 (Linking)
VI  - 45
IP  - 5
DP  - 2011 May
TI  - Vitamin D status and response to daily 400 IU vitamin D3 and weekly alendronate 
      70 mg in men and women with osteoporosis.
PG  - 561-8
LID - 10.1345/aph.1P439 [doi]
AB  - BACKGROUND: Suboptimal vitamin D status is common in elderly individuals. 
      However, the extent of vitamin D inadequacy in men and women being treated for 
      osteoporosis in a family practice setting has not been well characterized. 
      OBJECTIVE: To describe the distribution of serum 25-hydroxyvitamin D (25-[OH] D) 
      in Canadian men and postmenopausal women with osteoporosis taking 400 IU or less 
      of vitamin D daily and to evaluate the safety, tolerability, and impact of 
      vitamin D(3) supplementation 400 IU daily taken concurrently with alendronate 
      sodium 70 mg weekly. METHODS: This was a prospective, single-cohort, open-label, 
      multicenter study. Community-dwelling men and postmenopausal women with 
      osteoporosis were recruited at 197 sites across Canada. Patients received vitamin 
      D(3) 400 IU/day supplementation coadministered with alendronate 70 mg/wk for 16 
      weeks. The primary outcome was the distribution of serum 25-(OH) D at baseline. 
      Secondary outcome measures included changes from baseline in serum 25-(OH) D 
      levels, adherence to study treatments, and incidence of treatment-related adverse 
      events (AEs). RESULTS: Of the 681 patients included in the analysis, 485 (71.2%) 
      completed the study. Patients were predominantly female (83.1%) with a mean (SD) 
      age of 67.6 (10.7) years. At baseline, mean (SD) serum 25-(OH) D concentration 
      was 25.4 (9.9) ng/mL and 68.0% of the patients had inadequate (less than 30 
      ng/mL) vitamin D status. At week 16, concentrations increased by 35.1% to 31.2 
      (9.2) ng/mL (p < 0.001) and the proportion of patients with inadequate 25-(OH) D 
      levels was reduced to 47.0%. Adherence to the treatment regimen was high (greater 
      than 95%). Gastrointestinal disorders were the most frequently reported (6.9%) 
      treatment-related AEs. CONCLUSIONS: About two thirds of patients previously 
      diagnosed with osteoporosis have inadequate vitamin D status. A treatment regimen 
      consisting of alendronate 70 mg/wk administered with daily vitamin D(3) 400 IU 
      supplementation significantly increased patients' serum 25-(OH) D levels, but 47% 
      did not achieve optimal levels. These results support both the National 
      Osteoporosis Foundation and Osteoporosis Canada recommendations for higher 
      vitamin D supplement doses (at least 800 IU daily) in osteoporotic patients 
      receiving pharmacologic therapy for osteoporosis and for monitoring their serum 
      25-(OH) D response.
FAU - Karaplis, Andrew C
AU  - Karaplis AC
AD  - Division of Endocrinology, Department of Medicine, McGill University, Montreal, 
      Quebec, Canada.
FAU - Chouha, Fridon
AU  - Chouha F
FAU - Djandji, Michel
AU  - Djandji M
FAU - Sampalis, John S
AU  - Sampalis JS
FAU - Hanley, David A
AU  - Hanley DA
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110426
PL  - United States
TA  - Ann Pharmacother
JT  - The Annals of pharmacotherapy
JID - 9203131
RN  - 0 (Bone Density Conservation Agents)
RN  - 1406-16-2 (Vitamin D)
RN  - 1C6V77QF41 (Cholecalciferol)
RN  - A288AR3C9H (25-hydroxyvitamin D)
RN  - X1J18R4W8P (Alendronate)
SB  - IM
MH  - Aged
MH  - Alendronate/*therapeutic use
MH  - Bone Density Conservation Agents/*therapeutic use
MH  - Canada
MH  - Cholecalciferol/*administration & dosage/adverse effects
MH  - Cohort Studies
MH  - Dietary Supplements
MH  - Female
MH  - Humans
MH  - Male
MH  - Osteoporosis/blood/*drug therapy
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Vitamin D/analogs & derivatives/blood
EDAT- 2011/04/28 06:00
MHDA- 2011/09/16 06:00
CRDT- 2011/04/28 06:00
PHST- 2011/04/28 06:00 [entrez]
PHST- 2011/04/28 06:00 [pubmed]
PHST- 2011/09/16 06:00 [medline]
AID - aph.1P439 [pii]
AID - 10.1345/aph.1P439 [doi]
PST - ppublish
SO  - Ann Pharmacother. 2011 May;45(5):561-8. doi: 10.1345/aph.1P439. Epub 2011 Apr 26.