Objectives: To assess the effect of Teriparatide, Alendronate, and Zoledronic Acid on treatment of secondary osteoporosis. Design: a randomized clinical trial. Setting and conduct: The eligible patients with osteoporosis who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial. Inclusion criteria: (a) secondary osteoporosis; (b) T-score less than -2.5 in the lumbar spine or femoral neck. Exclusion criteria: (a) primary osteoporosis; (b) using prednisolone more than 3 months; (c) rheumatologic disease; (d) malignancy; (e) hypothyroidism; (f) renal failure; (g) history of surgery of parathyroid gland. Intervention group 1: Teriparatide 20 mcg daily subcutaneously for one year. Intervention group 2: Alendronate 70 mg weekly orally for one year. Intervention group 3: Zoledronic Acid 4 mg subcutaneously at the beginning of treatment and 6 months later. Intervention group 4: Teriparatide 20 mcg daily subcutaneously for 6 months and then Alendronate 70 mg weekly orally for 6 months. Control group: No control group. Primary outcome: Assessing the bone density before treatment and one year later using Dual X-ray Absorptiometry. Secondary outcome: Assessing the bone density before treatment and one year later using T-score. Randomization: Random assignment of the patients to the intervention and control groups one at a time. Blinding: Not blinding
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605159014N98
Registration date:2016-05-18, 1395/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Teriparatide, Alendronate, and Zoledronic Acid on treatment of secondary osteoporosis: a randomized clinical trial
Public title
Effect of Teriparatide, Alendronate, and Zoledronic Acid on treatment of secondary osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) secondary osteoporosis; (b) T-score less than -2.5 in the lumbar spine or femoral neck.
Exclusion criteria: (a) primary osteoporosis; (b) using prednisolone more than 3 months; (c) rheumatologic disease; (d) malignancy; (e) hypothyroidism; (f) renal failure; (g) history of surgery of parathyroid gland.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: Not blinding.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.506
Health conditions studied
1
Description of health condition studied
Secondary osteoporosis
ICD-10 code
M80
ICD-10 code description
Osteoporosis with pathological fracture
Primary outcomes
1
Description
Assessing the bone density
Timepoint
before treatment and one year later
Method of measurement
using Dual X-ray Absorptiometry
Secondary outcomes
1
Description
Assessing the bone density
Timepoint
before treatment and one year later
Method of measurement
using T-score
Intervention groups
1
Description
Intervention group 1: Teriparatide 20 mcg daily subcutaneously for one year.
Category
Treatment - Drugs
2
Description
Intervention group 2: Alendronate 70 mg weekly orally for one year.
Category
Treatment - Drugs
3
Description
Intervention group 3: Zoledronic Acid 4 mg subcutaneously at the beginning of treatment and 6 months later.
Category
Treatment - Drugs
4
Description
Intervention group 4: Teriparatide 20 mcg daily subcutaneously for 6 months and then Alendronate 70 mg weekly orally for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Ali Pouladrag
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan University of Medical Sciences
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
Shahid Beheshti Hospital
Full name of responsible person
Dr Ali Pouladrag
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
alipouladrag@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Zahra Basiri
Position
Rheumatologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
zbasiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)