Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

NCT00361595 | Completed Results

• 1 other identifier: CZOL446HUS120
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis

Keywords

osteoporosis; zoledronic acid; forteo

Outcome Measures

Primary Outcomes (1)

• Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)

  Baseline and 12 months

Secondary Outcomes (3)

• Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months

  6 months and 12 months

• Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)

  12 months

• Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)

  12 months

Study Arms (1)

open label

EXPERIMENTAL

5 mg zoledronic acid in a single 15 minute IV

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

5 mg zoledronic acid administered in a single 15 minute IV

Also known as: zometa

open label

Eligibility Criteria

• Age: Up to 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any prior use of strontium ranelate or sodium fluoride
• Chronic use of systemic corticosteroids (oral or i.v.) within the last year:
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chad Deal
• Organization: Cleveland Clinic

dealc@ccf.org

216-444-6575

Study Officials

• Chad Deal, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chad Deal, M.D.

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 21, 2017
• Results First Posted: January 14, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)