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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Recruitment Status : Withdrawn (physician departure)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

Tracking Information
First Submitted Date  ICMJE April 22, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date December 5, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01841814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy
Official Title  ICMJE Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lymphoma
  • Osteoporosis
Intervention  ICMJE Radiation: Bone densitometry.
Study Arms  ICMJE Experimental: lymphoma
Intervention: Radiation: Bone densitometry.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 3, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
50
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841814
Other Study ID Numbers  ICMJE PI11-DR-DAMAJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gandhi DAMAJ, Doctor CHU d'Amiens France
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP