Purpose: The purpose of this study was to examine the effect of Pamidronate on bone pains in Cancer patients.
Design: This study was carried out on 41 patients with malignancy in Imam Sajad Hospital of Ramsar.
Setting and conduct: This quasi-experimental study was carried out through convenience sampling method using a questionnaire and Visual Analog Scale (VAS).
Inclusion criteria: Malignancy with bone metastasis
Exclusion criteria: Renal dysfunction history or Creatinine more than 2mg/dl, Treatment of Hypocalcemia with other Bisphosphonates
Intervention: In this study, Pamidronate (90 mg) was intravenously injected up to 3 months (one per month).
Main outcome measures: Bone pains
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013032212197N5
Registration date:2013-05-05, 1392/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-05, 1392/02/15
Registrant information
Name
Maryam Zakerihamidi
Name of organization / entity
Tonekabon Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 19 1224 5014
Email address
maryamzakerihamidi@yahoo.co.nz
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tonekabon Islamic Azad University
Expected recruitment start date
2010-02-04, 1388/11/15
Expected recruitment end date
2011-02-04, 1389/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pamidronate on bone pains in patients with Malignancy
Public title
Effect of Pamidronate on treatment of bone pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Malignancy with bone metastasis
Exclusion criteria:
Renal dysfunction history,
Creatinine more than 2mg/dl,
Treatment of Hypocalcemia with other Bisphosphonates
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tonekabon Islamic Azad University
Street address
Islamic Azad University,Tonekabon, Vali Abad, Mazandaran, Iran
City
Tonekabon
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
364د/91
Health conditions studied
1
Description of health condition studied
Bone pains in Cancer patients with bone metastases
ICD-10 code
C79.5
ICD-10 code description
Secondary malignant neoplasm of bone and bone marrow
2
Description of health condition studied
Hypercalcemia in Cancer patients with bone metastases
ICD-10 code
E83.5
ICD-10 code description
Disorders of calcium metabolism
3
Description of health condition studied
Quality of life in Cancer patients with bone metastases
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Bone pains
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Visual Analoge Scale
Secondary outcomes
1
Description
Taking Sedatives
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Questionnaire including Clinical data
2
Description
Taking Opiums
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Questionnaire including Clinical data
Intervention groups
1
Description
In this study, Pamidronic Acid Ampule (90 mg) with Pamidronate brand name (Made in Hospira company) was intravenously injected for 3 months (one per month) along with 500 mL of Normal Saline during 2-4 hours. Data gathered through Clinical data Questionnaire and Visual Analog Scale (VAS) were compared before and after intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajad Hospital of Ramsar
Full name of responsible person
Dr Shahrbanoo Keyhanian
Street address
Imam Sajad Hospital of Ramsar, Motahari St., Ramsar, Mazandaran, Iran
City
Ramsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tonekabon Islamic Azad University
Full name of responsible person
Dr Hossein Ali Mashayekhi
Street address
Vice chancellor for research, Tonekabon Islamic Azad University
City
Tonekabon
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tonekabon Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Vice chancellor for research of Tonekabon Islamic Azad University
Full name of responsible person
Dr Hossein Ali Mashayekhi
Position
Vice chancellor for research/PhD of Chemistry
Other areas of specialty/work
Street address
Vice chancellor for research, Tonekabon Islamic Azad University, Tonekabon, Mazandaran, Iran
City
Tonekabon
Postal code
Phone
+98 19 2427 1105
Fax
Email
moaven.rsch.@tonekaboniau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tonekabon Islamic Azad University
Full name of responsible person
Dr Hossein Ali Mashayekhi
Position
PHD of Chemistry
Other areas of specialty/work
Street address
Vice chancellor for research, Tonekabon Islamic Azad University, Tonekabon, Mazandaran, Iran
City
Tonekabon
Postal code
Phone
+98 19 2427 1105
Fax
Email
moaven.rsch.@tonekaboniau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Obstetrics Department, Tonekabon Islamic Azad University
Full name of responsible person
Maryam Zakerihamidi
Position
Faculty member of Tonekabon Islamic Azad University/PhD student of Reproductive Health
Other areas of specialty/work
Street address
Obstetrics Department, Islamic Azad University, Tonekabon, Mazandaran, Iran
City
Tonekabon
Postal code
Phone
00
Fax
Email
maryamzakerihamidi@yahoo.co.nz
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)