Heartland Osteoporosis Prevention Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Osteoporosis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 9/29/2018 |
| Start Date: | February 2015 |
| End Date: | June 2019 |
Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women
The purpose of this study is to identify the best way to prevent bone loss in the first years
after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take
calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication
"risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading
exercises. Our central hypothesis is that improvements in bone health will be greater in
women randomized to bone-loading exercises with calcium and vitamin D compared to women who
take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take
calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication
"risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading
exercises. Our central hypothesis is that improvements in bone health will be greater in
women randomized to bone-loading exercises with calcium and vitamin D compared to women who
take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
This randomized controlled trial (RCT) will compare changes after 12 months in bone
structure, bone mineral density (BMD), and bone turnover in women with low bone mass who are
within 5 years of menopause. Women will be randomized to one control and 2 treatment groups
(n =103 per group): 1) calcium + vitamin D (CaD) alone (Control); 2) Bisphosphonate (BP) plus
optimal CaD (Risedronate); and 3) a bone loading exercise program plus optimal CaD
(Exercise). Our central hypothesis is that improvements in bone health will be greater in
subjects randomized to the exercise group compared to subjects in either the control or
risedronate groups. Specific Aims: Aims 1, 2, and 3 are to compare control, risedronate, and
exercise group subjects on changes in bone structure at the tibia and hip (measured by pQCT
and Hip Structural Analysis) (Aim 1) ; on changes in BMD at the total hip, femoral neck, and
spine (Aim 2); and on changes in serum markers of bone formation and resorption (Aim 3). In
addition, Aim 4 will explore relationships between adherence to exercise (% sessions
attended) or adherence to risedronate (% pills taken) and changes in bone structure.
structure, bone mineral density (BMD), and bone turnover in women with low bone mass who are
within 5 years of menopause. Women will be randomized to one control and 2 treatment groups
(n =103 per group): 1) calcium + vitamin D (CaD) alone (Control); 2) Bisphosphonate (BP) plus
optimal CaD (Risedronate); and 3) a bone loading exercise program plus optimal CaD
(Exercise). Our central hypothesis is that improvements in bone health will be greater in
subjects randomized to the exercise group compared to subjects in either the control or
risedronate groups. Specific Aims: Aims 1, 2, and 3 are to compare control, risedronate, and
exercise group subjects on changes in bone structure at the tibia and hip (measured by pQCT
and Hip Structural Analysis) (Aim 1) ; on changes in BMD at the total hip, femoral neck, and
spine (Aim 2); and on changes in serum markers of bone formation and resorption (Aim 3). In
addition, Aim 4 will explore relationships between adherence to exercise (% sessions
attended) or adherence to risedronate (% pills taken) and changes in bone structure.
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.
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