Abstract

To assess the treatment effect of oral alendronate 10 mg/day versus placebo on the change in BMD of the spine when administered for up to 24 months in men with osteoporosis. To define the safety/tolerability profile of oral alendronate when administered in men with osteoporosis. To assess the treatment effects of alendronate 10 mg/day versus placebo on the change in hip and total body BMD when administered for 24 months in men with osteoporosis. To examine the effects of alendronate 10 mg/day on biochemical markers of bone turnover (urinary N-telopeptide crosslinks and serum bone-specific alkaline phosphatase) in men with osteoporosis. To examine the relationship between the changes in bone mass at the spine and baseline: (a) BMD, (b) biochemical markers of bone turnover (c) gonadal status (d) age (e) geographic location (U.S. vs non-U.S.) (f) renal function (g) height.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001070-23
Application #
6265518
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
23
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29425

  Publications

Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 41:120-127
Putterman, Chaim; Pisetsky, David S; Petri, Michelle et al. (2018) The SLE-key test serological signature: new insights into the course of lupus. Rheumatology (Oxford) 57:1632-1640
Hall, Jordan T; Ebeling, Myla; Shary, Judy R et al. (2018) The relationship between physical activity and vitamin D status in postpartum lactating and formula-feeding women. J Steroid Biochem Mol Biol 177:261-265
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Response to Comment on Kelly et al. Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 2018;41:120-127. Diabetes Care 41:e102-e103
Bell, Katherine A; Wagner, Carol L; Perng, Wei et al. (2018) Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr 196:168-174.e1
Sen, Sarbattama; Penfield-Cyr, Annie; Hollis, Bruce W et al. (2017) Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr 187:147-152.e1
Wolf, Bethany J; Spainhour, John C; Arthur, John M et al. (2016) Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol 68:1955-63
Wagner, C L; Baggerly, C; McDonnell, S et al. (2016) Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates. J Steroid Biochem Mol Biol 155:245-51
Hollis, Bruce W; Wagner, Carol L (2016) Response to commentary by D Roth. Evid Based Med 21:120
Hollis, Bruce W; Wagner, Carol L; Howard, Cynthia R et al. (2015) Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics 136:625-34

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