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

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ClinicalTrials.gov Identifier: NCT01841814
Recruitment Status : Withdrawn (physician departure)
First Posted : April 29, 2013
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Lymphoma Osteoporosis Radiation: Bone densitometry. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.
Study Start Date : April 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lymphoma Radiation: Bone densitometry.



Primary Outcome Measures :
  1. Measurement of bone mineral density (BMD). [ Time Frame: Change from Baseline of bone mineral density at 12 months. ]
    Patients will have a review of bone densitometry.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841814


Locations
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France
Gandhi DAMAJ
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Gandhi DAMAJ, Doctor CHU d'Amiens France

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01841814     History of Changes
Other Study ID Numbers: PI11-DR-DAMAJ
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Lymphoma
Osteoporosis
Chemotherapy
Patient with
Additional relevant MeSH terms:
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Lymphoma
Osteoporosis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases