The purpose of this study is to evaluate the efficacy of oral ibandronate (versus placebo) added to the standard radiotherapy regimen for painful bone metastases to reduce pain, to reduce the need of analgesics, and to reduce skeletal-related events…
ID
Bron
Verkorte titel
Aandoening
prostate cancer, metastases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary objective will be pain reduction on the pain scale (scale 0-10) at 12 weeks of treatment. Response of treatment will be defined as a reduction of at least two points of the pain scale.
Achtergrond van het onderzoek
Although radiotherapy is highly effective to treat painful bone metastases of PC, the rate of re-treatment is considerable, and re-treatment of the same metastases needs to be done often after a short time and with a low response rate.
Ibandronate, 50 mg administered on a daily base for 6 months, might be effective to reduce pain from bone metastases, to reduce the need of analgesics, and to reduce the need of re-treatments with radiotherapy or other interventions.
Doel van het onderzoek
The purpose of this study is to evaluate the efficacy of oral ibandronate (versus placebo) added to the standard radiotherapy regimen for painful bone metastases to reduce pain, to reduce the need of analgesics, and to reduce skeletal-related events (impending fractures, need of repeated radiotherapy, or surgery).
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Ibandronaat tablet or placebo.
Algemeen / deelnemers
P.O. Box 5201
L. Incrocci
Groene Hilledijk 301
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391421
l.incrocci@erasmusmc.nl
Wetenschappers
P.O. Box 5201
L. Incrocci
Groene Hilledijk 301
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391421
l.incrocci@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Karnofsky score „d60%;
2. Written informed consent;
3. Histologically proven PC with documented (bone scintigraphy, CT scan, MRI, or conventional X-Ray) bone metastases, without spinal cord/cauda equina compression;
4. Indication for analgesic radiotherapy;
5. Estimated life expectancy of „d6 months;
6. Clinically documented painful bone metastases;
7. Indication for analgesic radiotherapy for the painful bone metastases.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous treatment with any kind of bisphosphonates or radionuclides;
2. Hypercalcemia (serum calcium level >2.65 mmol/L), hypocalcemia (serum calcium level <2.2 mmol/L), impaired renal function (creatinine >266 umol/L; albumin >50 g/L), according to the medical charts;
3. Investigational drugs within 30 days before study entry;
4. Paget¡¦s disease;
5. Untreated esophagitis or gastric ulcer.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL462 |
| NTR-old | NTR503 |
| Ander register | : N/A |
| ISRCTN | ISRCTN55471205 |