Research with human participants

Overview of medical research in the Netherlands

BONE MINERAL DENSITY IN PROSTATE CANCER PATIENTS TREATED WITH ANDROGEN DEPRIVATION THERAPY

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To assess whether a change in BMD as detected big DXA (gold standard) is comparable with the decline measured by the achilles method

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Bone, calcium, magnesium and phosphorus metabolism disorders
Study type
Observational invasive

ID

NL-OMON37103

Source

ToetsingOnline

Brief title

BMD during ADT

Condition

  • Bone, calcium, magnesium and phosphorus metabolism disorders
  • Renal and urinary tract neoplasms malignant and unspecified

Synonym

bone loss, osteoporosis

Research involving

Human

Sponsors and support

Primary sponsor :
Sint Franciscus Gasthuis
Source(s) of monetary or material Support :
Abbott,grant van farmaceutische industrie

Intervention

Keyword :
Achilles, androgen deprivation, Bone mineral density, prostate cancer

Outcome measures

Primary outcome

Compare the change in BMD between the 2 modalities

Secondary outcome

describe course of BMD of both modalities

Identify factors that influence the BMD pattern

Background summary

ADT can cause osteoporosis. Recognition of patients in whom a decline in BMD
will occur is difficult

Study objective

To assess whether a change in BMD as detected big DXA (gold standard) is
comparable with the decline measured by the achilles method

Study design

serial BMD measurements by achilles and DXA-scan

Study burden and risks

see above

Public
Sint Franciscus Gasthuis

Kleiweg 500
3045PM
NL
Scientific
Sint Franciscus Gasthuis

Kleiweg 500
3045PM
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Prostate cancer
androgen deprivation according to Bolla schedule

Exclusion criteria

osteoporosis
treatment with bisphophonates or RANK-ligand inhibitor

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
51
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
TWOR: Toetsingscommissie Wetenschappelijk Onderzoek Rotterdam e.o. (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL40673.101.12