Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Risedronate; Parathyroid Hormone
Intervention description: One 35mg tab of risedronate/placebo taken once a week for one year.; This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
Intervention MeSH terms: Risedronic Acid; Hormones; Parathyroid Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoporosis; Steroids; Prednisone

Summary:

      The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH),
      either alone or with risedronate, will increase the thickness of the bones in the hip and
      spine in subjects with osteoporosis from chronic low dose steroid use. During the second
      year, the study will also look at whether taking risedronate will preserve the bone thickness
      created by one year of rhPTH 1-34 treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, greater than 18 years of age with a history of glucocorticoid therapy
             with prednisone ≥ 7.5mg/d for 6 months, and currently on prednisone ≥ 5mg /day.

          -  DXA of the lumbar spine (L1-L4) or total hip or femoral neck T score ≤ -1.5 with or
             without a prevalent vertebral fracture. (The T score is the number of standard
             deviations above or below the population mean for young, normal pre-menopausal females
             age 30).

          -  Investigators are satisfied that that there is no physical condition that would
             prevent a patient from receiving the proposed treatment regimens.

          -  Patient is ambulatory and able to return to the site of the investigation at specified
             time during the study.

          -  The patient is willing to participate in the proposed study as evidenced by signing an
             informed consent.

          -  Women of childbearing age are willing to use 2 forms of contraception during the
             entire study period.

          -  Have at least one analyzable BMD site: lumbar spine and/or proximal femur

        Exclusion Criteria:

          -  Generalized disease of bone other than related to a rheumatic disease and
             glucocorticoid-induced osteoporosis including: hyperparathyroidism,
             hypoparathyroidism, Paget's disease of bone

          -  Diseases that may affect bone metabolism including: alcoholism, hyperthyroidism, renal
             impairment (creatinine > 2.5mg/dl) or hepatic impairment (SGOT levels > 2x upper limit
             of normal

          -  Urinary excretion of calcium > 400mg/day

          -  History of drug abuse

          -  Previous use of alendronate within 6 months prior to the study

          -  Previous use of risedronate, hormone replacement therapy or calcitonin within 2 months
             prior to the study

          -  History of unstable cardiovascular disease or uncontrolled hypertension

          -  Severe scoliosis, greater than 2 lumbar fractures, or spinal surgery such that a
             precise bone mass measurement could be affected

          -  History of gastrointestinal intolerance to bisphosphonates

          -  History of cancer within 5 years of the study

          -  Patients on glucocorticoids for organ transplantation