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

Lymphoma Clinical Trial

— LYMPHOS  

Official title:

Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01841814
• Other study ID #: PI11-DR-DAMAJ
• Status: Withdrawn
• Phase: Phase 4
• First received: April 22, 2013
• Last updated: December 2, 2016
• Start date: April 2013
• Est. completion date: April 2013

Study information

• Verified date: December 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: FRANCE: National Security Agency of Medicines and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Osteoporosis

Intervention

Radiation:
• Bone densitometry.

Locations

Country	Name	City	State
France	Gandhi DAMAJ	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of bone mineral density (BMD).	Patients will have a review of bone densitometry.	Change from Baseline of bone mineral density at 12 months.	No