Heartland Osteoporosis Prevention Study (HOPS)
Osteopenia
About this trial
This is an interventional treatment trial for Osteopenia focused on measuring Low bone mass, Post-menopausal women, Bone mineral density, Bone structure, Bone turnover, Bone-loading exercises, calcium and vitamin D, risedronate
Eligibility Criteria
Inclusion Criteria:
- Women who are in their first 5 years of menopause
- Have a T score between -1 and -2.49 at the femoral neck, total hip, or L1-L4 spine
- Be 19 years of age or older
- Have their health care provider's permission to enroll in the study.
Exclusion Criteria:
- Have osteoporosis
- Have a 10 yr probability of hip fracture >3% or major fracture >20% based on results of the fracture risk assessment (FRAX) tool
- Currently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone
- Currently participate in a resistance training or high impact weight bearing exercise program three or more times weekly
- Weigh >300 lbs
- Have abnormal results for the following laboratory tests: serum 25(OH)D; serum creatinine; serum calcium; parathyroid hormone (PTH); thyroid stimulating hormone (TSH).
- Have Paget's disease, heart disease, uncontrolled hypertension, renal disease, or other concomitant conditions that prohibit participation in exercises, risedronate therapy, or use of CaD supplements.
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control
Risedronate
Exercise
Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3.
Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes.
Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains.