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

Primary Purpose

Lymphoma, Osteoporosis

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Bone densitometry.
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring Lymphoma, Osteoporosis, Chemotherapy, Patient with

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gandhi DAMAJ

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lymphoma

Arm Description

Outcomes

Primary Outcome Measures

Measurement of bone mineral density (BMD).
Patients will have a review of bone densitometry.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
December 2, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01841814
Brief Title
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy
Acronym
LYMPHOS
Official Title
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
physician departure
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Osteoporosis
Keywords
Lymphoma, Osteoporosis, Chemotherapy, Patient with

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lymphoma
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Bone densitometry.
Primary Outcome Measure Information:
Title
Measurement of bone mineral density (BMD).
Description
Patients will have a review of bone densitometry.
Time Frame
Change from Baseline of bone mineral density at 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gandhi DAMAJ, Doctor
Organizational Affiliation
CHU d'Amiens France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gandhi DAMAJ
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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

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