Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Roche Pharma AG
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00824993

Purpose

The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer.

This study plans to address the following hypotheses:

The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders.
BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate.

Specific objectives to test these hypotheses are:

Primary Objective:

1. To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center.
Secondary Objectives:
1. To measure and compare the accumulated level of steroid used in both treatment and control groups.
2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study.
3. To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
4. To record incidence of bone fractures and the graft rate in both treatment and control groups.

Condition	Intervention	Phase
Hematological Malignancies	Drug: Ibandronate Drug: Vitamin Supplements	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Controlled Study of Ibandronate for the Prevention of Bone Loss in Patients Who Have Received Allogeneic Bone Marrow Transplantation for Hematological Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Bone Marrow Transplantation Calcium Cancer Minerals Osteoporosis Vitamin D

Drug Information available for: Ibandronic acid Ibandronate sodium Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Percent Reduction in Bone Mineral Density (BMD) of the lumbar spine, femoral neck, and total hip [ Time Frame: Baseline to 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Ibandronate + Calcium + Vitamin D	Drug: Ibandronate Infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant. Other Name: Boniva Drug: Vitamin Supplements Calcium 500 mg by mouth everyday for 12 months Vitamin D 400 units by mouth 2 times a day for 12 months
Experimental: Group 2 Calcium + Viatmin D	Drug: Vitamin Supplements Calcium 500 mg by mouth everyday for 12 months Vitamin D 400 units by mouth 2 times a day for 12 months

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years.
Patients with the diagnosis of hematologic malignancies or hematological disorders, who are immediately post- allogeneic bone marrow transplantation.
Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
Negative pregnancy test in premenopausal patients.
Patients with GVHD or infections can be entered only if they respond to treatment and become controlled.
Dental considerations: patients with negative dental screening for jaw osteonecrosis 0-3 months prior to their transplant and patients that do not have a plan for tooth extraction in the near future.

Exclusion Criteria:

Patients with documented relapsed malignancy or recurrence of the original hematological disorder after the transplant, uncontrolled acute GVHD, or uncontrolled infection.
Patients with hypocalcemia of less than 8.4 (corrected to account for the albumin level).
Patients with hypercalcemia >12.2, due to a cause not related to their hematological malignancy or hematological disorder (i.e. hyperparathyroidism, multiple myeloma).
Hypersensitivity to Ibandronate or other bisphosphonates.
Pre-existing osteoporosis, defined as a bone density T-score of -2.5 S.D. or less.
Renal insufficiency (calculated creatinine clearance < 30 ml/min).
Patients already on bisphosphonates (over the past two years), calcitonin, anabolic steroids, or daily oral fluoride supplement.
Myeloma patients who have previously been on bisphosphonates over the past two years and/or have active bone lesions.
If corrected calcium is above 10.3 and the iPTH is elevated or normal, the patient will be excluded from the study.
Patients with a 25-hydroxyvitamin D concentration <20 ng/ml and evidence of osteomalacia (low ionized calcium and elevated intact PTH).
Dental considerations: Patients with recent tooth extraction with signs of incomplete healing or significant infection will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824993

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Roche Pharma AG

Investigators

Principal Investigator:

Huifang Lu, MD, PHD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00824993 History of Changes
Other Study ID Numbers:	2006-0960
Study First Received:	January 15, 2009
Last Updated:	October 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Blood Cancer
Calcium
Vitamin D
Ibandronate
Boniva
Hematological Malignancies

Bone Marrow Transplantation
BMT
Osteoporosis
Bone Loss
Allogeneic Bone Marrow Transplantation

Additional relevant MeSH terms:

Neoplasms
Osteoporosis
Hematologic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Site
Hematologic Diseases
Ibandronic acid

Vitamin D
Diphosphonates
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012