Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Teriparatide; Zoledronic Acid

Criteria

Inclusion Criteria:

• Postmenopausal women to age 85, inclusive

• Finish treatment of 12 months or longer with Forteo

• Signed informed consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

• Hip and spine DXA T-score >-1.0

• Patients with 25-(OH) vitamin D levels less than 15 ng/mL at Visit 1. (Patient can be repleted with vitamin D 50,000 units biweekly for up to 2 months and re-screened anytime during the 2 months while continuing Forteo.)

• Baseline renal insufficiency (calculated creatinine clearance less than 40.0 mL/min (MDRD) at Visit 1 and/or Visit 2 or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with calculated creatinine clearance equal to or greater than 40.0 mL/min and less than 60.0 mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must be retested between Visit 1 and 2. Patients with calculated creatinine clearance greater than 60.0 mL/min and serum creatinine within normal limits at Visit 1 do not require re-test.

• Patients who require re-test of creatinine clearance between Visit 1 and 2 will be excluded if there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1 and Visit 2.

• Serum calcium <8.5 or >11.0 mg/dl at Visit 1

• AST or ALT greater than twice the upper limit of normal

• Serum alkaline phosphatase greater than 1.5 times the upper limit of normal (liver fraction)

• No history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM with Hb1 AC > 10%

• Hypersensitivity to bisphosphonates

• Treatment with biphosphonates while on Forteo

• Prior treatment with i.v. biphosphonates

• Estrogen, calcitonin, raloxifene use prior to Forteo treatment are not exclusions, but concomitant therapy during with any bone agents during the trial will not be permitted

• Any prior use of strontium ranelate or sodium fluoride

• Chronic use of systemic corticosteroids (oral or i.v.) within the last year:

NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary.

• Prior exposure to anabolic steroids or growth hormone within 6 months prior to randomization

• Treatment with any investigational drug(s) and/or devices within 30 days prior to randomization.

• History of iritis or uveitis, except when secondary to trauma, and must have resolved for more than 2 years prior to randomization.

• Cancer exclusions:

• Patients with a new diagnosis or active treatment for any malignancy less than or equal to 12 months prior to Visit 1.

• Patients with evidence of any metastases on or prior to randomization, or with a history of metastases

• Subjects with evidence of paraneoplastic syndrome, especially those characterized by hypercalcemia during screening or by history

• Patients with the following may be included: basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, and Carcinoma in-situ (CIS) of the prostate (Stage I only) that has been surgically removed.

• Previous major solid organ or bone marrow transplant recipient or on a transplant waiting list

• Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA (L1-L4) e.g., implantable devices, scoliosis, ankylosing spondylitis, DJD. (Less than two lumbar spine vertebral bodies evaluable)

• Active primary hyperparathyroidism or hypoparathyroidism

• Subject with complete thyroidectomy

• Active hyperthyroidism

• Hypothyroidism not treated with adequate replacement therapy

• History of multiple myeloma or Paget's disease

• Patients with severe dental problems or current dental infections, or with recent or impending dental surgery within three months of dosing

• Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol