Osteoporosis
Conditions
Brief summary
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).
Detailed description
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
Interventions
DRUGteriparatide
Teriparatide
Sponsors
University of Kansas
Leland Graves III, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide
Exclusion criteria
* Patients with diabetes mellitus * current smokers * patients with a history of organ transplantation * Patients currently of previously on glucocorticoid therapy within the past year * Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater) * Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis * History of radiation therapy * Patients pregnant or nursing * History of bone metastasis or skeletal malignancies * History of hypercalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels | baseline, 3, and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| CRP levels | Baseline and at 6 months of therapy |
Countries
United States
Outcome results
None listed