Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients

NCT00824993 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2006-0960NCI-2010-01024
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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.
2. 2.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.
3. 3.Primary Objective:
4. 4.Secondary Objectives:
5. 5.To measure and compare the accumulated level of steroid used in both treatment and control groups.
6. 6.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.
7. 7.To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
8. 8.To record incidence of bone fractures and the graft rate in both treatment and control groups.

Conditions

Hematological Malignancies

Keywords

Blood Cancer; Calcium; Vitamin D; Ibandronate; Boniva; Hematological Malignancies; Bone Marrow Transplantation; BMT; Osteoporosis; Bone Loss; Allogeneic Bone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months

  The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.

  Baseline to 6 months and Baseline to 12 months

Study Arms (2)

Ibandronate + Calcium + Vitamin D

EXPERIMENTAL

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. Calcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months.

Drug: Ibandronate; Drug: Vitamin Supplements

Calcium + Viatmin D

EXPERIMENTAL

Calcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months.

Drug: Vitamin Supplements

Interventions

Ibandronate DRUG

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.

Also known as: Boniva

Ibandronate + Calcium + Vitamin D

Vitamin Supplements DRUG

Calcium 500 mg by mouth everyday for 12 months Vitamin D 400 units by mouth 2 times a day for 12 months

Calcium + Viatmin D; Ibandronate + Calcium + Vitamin D

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 immunoreactive parathyroid hormone (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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Roche Pharma AG: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms; Osteoporosis; Bone Diseases, Metabolic

Interventions

Ibandronic Acid; Geritol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Lu,Huifang,M.D. PH.D. / General Internal Medicine
• Organization: UT MD Anderson Cancer Center

HLU@MDANDERSON.ORG

713-563-4462

Study Officials

• Huifang Lu, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: December 9, 2008
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: September 13, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-09

Locations

US (1)