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Studies Now Recruiting Participants

Please call 1-800-368-5097 or 402-280-BONE to inquire about our studies.

NOW RECRUITING PARTICIPANTS
A randomized study evaluating the effect on renal function of ibandronate administered as an i.v. bolus injection compared to an i.v. infusion, and alendronate oral administered once weekly, in postmenopausal women with osteoporosis at high risk for renal disease.(Roche Renal)
Principal Investigator: Robert R. Recker, MD, MACP, FACE.

The main purpose of this study is to further assess the effect on your kidneys of these treatments by examining your blood and urine samples. The effect of an ibandronate injection (3 mg every 3 months) will be compared to an ibandronate infusion (3 mg every three months), and an oral alendronate treatment (70 mg tablet taken by mouth once a week). Throughout the study, your kidney function will be carefully monitored.

Amount of time on study: 13 months
End of recruitment period: August 2008

Inclusion criteria: Women age 65 & older that are at least 5 years postmenopausal and have either been diagnosed with osteoporosis or have had a low trauma fracture after the age of 45.

Project manager: Jeanette LeMaster, RN, CCRC

Contact: Jeanette at (402) 280-4839

NOW RECRUITING PARTICIPANTS
Muscle Strength Study (Merck Muscle)
Principal Investigators: Robert R. Recker, MD, MACP, FACE.

This is a study to assess the effectiveness of an investigational drug on Sarcopenia (muscle loss) in older women.

Amount of time on study: 6 months
End of recruitment period: March 2008

Inclusion criteria: Women age 65 & older. Subjects must be willing to take an investigational medication or a placebo, protein and vitamin D supplements. Subjects will be asked to have a physical exam, including blood work, EKG, and to participate in physical agility testing.

Project Manager: Chris Von Buettner, RN, BSN
Co-Manager: Jennifer Larsen, RT,(R) (BD) (ARRT), CDT

Contact:
Chris at 402-280-4611
Jennifer at 402-280-4489

NOW RECRUITING PARTICIPANTS
Proteomics Study of Peripheral Blood Monocytes on Osteoporosis (Promo Study)
Principal Investigators: Robert R. Recker, MD, MACP, FACE.

Evidence exists that there is a genetic and molecular basis for osteoporotic fractures and bone mass. A type of white cell called monocytes play a role in the processes of bone mass changes and risk of fractures. The present study employs a technique that allows us to find out how protein products work in the cells. We thus can compare the data from people with and without hip fracture to identify protein products that may contribute to higher risk of fractures. It may be helpful for prevention of fractures and low bone mass.

Amount of time on study: 1 visit (45min to 1 hour)

Inclusion criteria: Women age 50 & older, who have experienced a hip fracture.

Exclusion criteria: Women can not be on hormones, osteoporosis medication, steroids, or seziure medications, and cannot have major health problems.

Project manager: Jennifer Larsen, RT,(R) (BD) (ARRT), CDT

Contact Jennifer at 402-280-4489

NOW RECRUITING PARTICIPANTS
Pilot Study to Investigate the Effect of Bonistein ™ Bone Blend Containing Genistein, Polyunsaturated Fatty Acids (N-3 PUFAS) and Vitamins K₁and D₃ on Bone Mineral Density (BMD), Bone Mineral Content (BMC), and Biomarkers of Bone Health in Early Postmenopausal Women (Bonistein Study).
Principal Investigators: Robert P. Heaney, MD, FACP, FACN

Study evaluating the potential effectiveness of a nutritional supplement on bone density. Eligible participants will receive, at no cost to them, a pre-study health screening which includes a bone density scan.

Amount of time on study: 6 months.

Inclusion criteria: Female, age 45-55, Caucasian, and post-menopausal for 1 to 3 years with no hysterectomy.

Exclusion criteria: Not currently taking osteoporosis medication or long term steroid therapy. No cancer, except for basal or squamous cell skin cancer.

Project managers: Margaret Begley, BA, BSN, RN or MarlaTheobald, RN

Contact Margaret at 402-280-4578 or Marla at 402-280-3635

NOW RECRUITING PARTICIPANTS
Pilot Project Preparatory to a Definitive Study of the Efficacy of Milk Mineral in Human Bone Health (Milk Mineral Study).
Principal Investigators: J. M. Lappe, RN, Ph.D. & Robert P. Heaney, MD, FACP, FACN

Study to see if milk minerals are as effective as milk and calcium carbonate on bone health.

Amount of time on study: 7 months.

Inclusion criteria: 5 - 10 years postmenopausal females; age 50+; currently consuming one or less servings of milk per day.

Exclusion criteria: No osteoporosis meds, hormone replacement, steroids or calcium supplements.

Project manager: Julie Stubby, RN, BSN

Contact Julie at 402-280-4958

NOW RECRUITING PARTICIPANTS
Osteoporosis in Premenopausal Women (Shane IOP Study).
Principal Investigator: Robert R. Recker, MD, MACP, FACE.

Have you been diagnosed with osteoporosis, or do you have a history of osteoporosis in your family? This is an opportunity to have a bone density scan to evaluate your bone health. The study involves an intensive work up for diagnosis of osteoporosis in premenopausal women.

Study eligibility requirements include: female, age 20-48, must be premenopausal and having regular periods.

Exclusions:

• no use of oral contraceptives, depot progesterone, estrogen preparations, raloxifene, or calcitonin within the last 3 months
• no use of bisphosphonates within the last 12 months or total exposure to bisphosphonates greater than 1 year
• no use of PTH, glucocorticoids, anticonvulsants, anticoagulants, diuretics, or methotrexate use ever
• no use of zolendronate within the past 2 years

Project manager: Jeanette LeMaster, RN, CCRC

Call 402-280-4839

We are also collaborating with Columbia University in New York City on this study.
Principal Investigator: Elizabeth Shane, M.D.
Study Coordinator: Dinaz Irani, M.D., CRC
If you would prefer to participate at the Columbia University site,
please call 212-305-7225.