Losing bone density as a result of osteoporosis can not be fully recovered by using oral method of treatment and the only remedy that is able to recover the lost bone mass, is recombinant form of human parathyroid hormone. The present study is carried out to assess treatment effects of recombinant form of human PTH compared to its brand type in a randomized double-blind clinical trial with two parallel groups. Patients are menopause women aged 45-75 years old who are under treatment and have severe osteoporosis, the severity of osteoporosis is determined by bone mass densitometry (DEXA method) and history of patients. In each group, patients receive daily single dose of subcutaneous recombinant form of PTH (1-34) or brand type . Data regarding bone mass densitometry are gathered in a fixed center by a similar technique of DEXA method before and 6 months after treatment and T-Scores that are related to lumbar vertebra, neck of femur, and total hip are considered as target points in treatment. Bone turn over markers are also measured at baseline, one, three and six months after treatment. A questionnaire including demographic data and risk factors for losing bone density is filled out for every patient. After encoding, data will be entered in SPSS software and finally will be analyzed.
General information
Acronym
rhPTH vs FORTEO
IRCT registration information
IRCT registration number:IRCT138810121414N5
Registration date:2010-09-22, 1389/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-22, 1389/06/31
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cinnagen Biotechnology
Expected recruitment start date
2011-02-01, 1389/11/12
Expected recruitment end date
2012-10-10, 1391/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis
Public title
Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Patients are menopause women aged 45-75 who have following conditions: A) T-score less than -3 in lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidences of fracture with low trauma due to osteoporosis. B) T-score less than -2.5 in one of mentioned regions due to osteoporosis with low trauma in vertebras or limbs. C) Women aged 55 and over with T-score less than -2.5 in one of regions of lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidence of fracture with low trauma due to osteoporosis. D) Women aged 55 and over with T-score less than -2 at one of mentioned regions with history of fracture due to osteoporosis and low trauma in vertebras or limbs.
Exclusion criteria:
A) Rejecting to take part in the study and anticipating lack of cooperation during treatment and follow up periods. B) History of taking bone resorption inhibitor medications such as; Bisphosphanates at least for four weeks. C) Having a disease or being under treatment that interacts with bone metabolism and disrupts treatment process like auto-immune diseases, long term taking of Corticosteroid, chemotherapy or radiotherapy, epilepsy under treatment. D) Hypercalcemia above 10 mg/dl or hypercalceuria with ratio of Uca/Ucr>0.35, history of receiving PTH or stransium, history of urinary stones, advanced stage of liver or kidney disorders, intestinal malabsorbtion, hyper& hypoparathyroidism, hyperthyroidism, history of cancer in 5 years before the first visit, hyperuricemia and gout, lactation.
Age
From 45 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine & Metabolism Research Institute
Street address
North Karegar St, Dr. Shariati Hospital
City
Tehran
Postal code
1411413137
Approval date
empty
Ethics committee reference number
E-0015
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81.0, M80
ICD-10 code description
Osteoporosis with and without pathological fracture
Primary outcomes
1
Description
Bone markers
Timepoint
1st, 3rd and 6th month of the study
Method of measurement
DEXA
2
Description
Bone mineral density (BMD)
Timepoint
At the beginning and 6 month after the start of study
Method of measurement
DXA
Secondary outcomes
1
Description
Fragility fracture prevention
Timepoint
6 mounths after the start of the study
Method of measurement
thoracolumbar & Hip radiography
Intervention groups
1
Description
Intervention group: Patients will receive daily dose of 20µg Cinagen rhPTH subcutaneously for 6 month. PTH will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Patients will receive daily dose of 20µg FORTEO subcutaneously for 6 month. FORTEO will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine & Metabolism Research Institute
Full name of responsible person
Dr. Ramin Heshmat
Street address
North Karegar St, Dr. Shariati Hospital, Endocrine & Metabolism Research Institute
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cinagen biotechnology
Full name of responsible person
Dr. Mahboodi
Street address
No.56, Azimi Alley, Phase 1, Ekbatan Complex
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cinagen biotechnology
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrine & Metabolism Research Istitute, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Heshmat
Position
Assistant Prof., Research Deputy, PhD Epidemiologist
Other areas of specialty/work
Street address
North Karegar St, Dr. Shariati Hospital
City
Tehran
Postal code
1411413137
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
rheshmat@tums.ac.ir
Web page address
http://emri.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Endocrine & Metabolism Research Istitute
Full name of responsible person
Dr. Ramin Heshmat
Position
Assistant Prof., Research Deputy
Other areas of specialty/work
Street address
North Karegar Ave. Shariati Hospital
City
Tehran
Postal code
1411413137
Phone
+98 21882200378
Fax
+98 21 8822 0052
Email
rheshmat@tums.ac.ir
Web page address
http://emri.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)