Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

NCT00580047 | Completed Results DMC FDA Drug

• 1 other identifier: 0437-02-FB
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

Conditions

Renal Insufficiency

Keywords

bone density; osteopenia; transplant; zoledronic acid; alendronate

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant

  Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.

  24 months

Secondary Outcomes (1)

• Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation

  24 months

Study Arms (3)

1 Zoledronic Acid

ACTIVE COMPARATOR

Zoledronic Acid 4mg intravenously once a year for 2 years

Drug: Zoledronic Acid

2 Alendronate

ACTIVE COMPARATOR

Alendronate 70mg orally once a week for 2 years

Drug: Alendronate

3 Placebo

PLACEBO COMPARATOR

Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily

Combination Product: Calcium with vitamin D

Interventions

Zoledronic Acid DRUG

4mg IV Annually

Also known as: Zometa

1 Zoledronic Acid

Calcium with vitamin D COMBINATION_PRODUCT

1200 mg Calcium with 800 International Units of vitamin D

Also known as: calcium citrate, calcium carbonate

3 Placebo

Alendronate DRUG

70mg weekly

Also known as: Fosamax

2 Alendronate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0

You may not qualify if:

• Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower
• History of more than one vertebral or non-vertebral fracture in the past two years
• Abnormalities of the esophagus which delay esophageal emptying
• Inability to stay upright for 30 minutes
• Pregnant, nursing women or women not using an effective form of birth control
• Hypocalcemia
• Hypercalcemia
• Calculated creatinine clearance of \<35 ml/min or serum creatinine \> 3.0
• Patients already treated with bisphosphonates within the past one year
• Patients unable to undergo DXA
• Patients with cancer

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (2)

• Wang J, Yao M, Xu JH, Shu B, Wang YJ, Cui XJ. Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials. Osteoporos Int. 2016 May;27(5):1683-90. doi: 10.1007/s00198-015-3465-7. Epub 2016 Jan 5.

  PMID: 26733377 BACKGROUND

• Shane E, Cohen A, Stein EM, McMahon DJ, Zhang C, Young P, Pandit K, Staron RB, Verna EC, Brown R, Restaino S, Mancini D. Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation. J Clin Endocrinol Metab. 2012 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28.

  PMID: 23024190 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Bone Diseases, Metabolic

Interventions

Zoledronic Acid; Calcium; Vitamin D; Calcium Citrate; Calcium Carbonate; Alendronate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; 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; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Calcium Compounds; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Limitations and Caveats

Small sample sizes and missing data.

Results Point of Contact

• Title: Lynn Mack
• Organization: University of Nebraska Medical Center

lmack@unmc.edu

402-559-6208

Study Officials

• Lynn Mack, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2003
• Primary Completion: July 29, 2014
• Study Completion: July 29, 2014
• Last Updated: October 4, 2023
• Results First Posted: March 19, 2018

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)