Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy

NCT01841814 | Withdrawn Phase 4

• 1 other identifier: PI11-DR-DAMAJ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.

Conditions

Lymphoma; Osteoporosis

Keywords

Lymphoma; Osteoporosis; Chemotherapy; Patient with

Outcome Measures

Primary Outcomes (1)

• Measurement of bone mineral density (BMD).

  Patients will have a review of bone densitometry.

  Change from Baseline of bone mineral density at 12 months.

Study Arms (1)

lymphoma

EXPERIMENTAL

Radiation: Bone densitometry.

Interventions

Bone densitometry. RADIATION

lymphoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 to 80 with lymphoma,
• Histological diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin lymphoma (NHL) of follicular or aggressive (large cell or other),
• Patients who have not yet started their chemotherapy or who have started for less than a month
• Patient has signed informed consent.

You may not qualify if:

• Pathological fractures at the time of initial diagnosis of lymphoma,
• Compression of neurological epidural,
• Patients receiving treatment for osteoporosis (including bisphosphonates, selective modulators of estrogen receptor, calcitonin and parathyroid hormone Teriparatide).
• Discovery of osteoporosis or osteopenia fracture during the initial evaluation requiring the establishment of an osteoporosis treatment,
• Radiotherapy to the lumbar spine or hip studied,
• Location of bone lymphoma in the lumbar spine or hip studied,
• History of disorders affecting bone metabolism (prostate cancer with androgen, stomach cancer, hyperparathyroidism, hyperthyroidism, uncontrolled ...)
• A person incapable of giving consent personally,
• Pregnant or breastfeeding women,
• Protected Person (under guardianship)
• Patient not affiliated with a social security system.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Gandhi DAMAJ

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Lymphoma; Osteoporosis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gandhi DAMAJ, Doctor

  CHU d'Amiens France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

FR (1)