Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,alendronate sodium in postmenopausal women with DTC under TSH suppression and osteoporosis.
Differentiated thyroid cancer (DTC) has become one of the most common endocrine malignancies. According to American Thyroid Association (ATA) and Chinese Thyroid Association (CTA), most of DTC patients undergo total or near total thyroidectomy, radioiodine ablation and TSH (thyroid stimulating hormone) suppression. Osteoporosis (OS) and fractures are important comorbidities in patients with DTC, with potential negative impact on quality of life (QOL) and survival. The main determinant of skeletal fragility in DTC is the TSH suppression. Postmenopausal women with DTC under TSH suppression therapy are more vulnerable to OS. Technetium-99 methylene diphosphonate (99Tc-MDP) is a decay product of 99mTc-MDP (used for bone scintigraphy) and a novel bisphosphonates, which has been used in China for diseases like rheumatoid arthritis (RA), ankylosing spondylitis (AS) and osteochondral lesions of the talus, etc. However, as a member of bisphosphates, little attention has been paid to its anti-OS effect for DTC under TSH suppression.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99Tc-MDP | Experimental | 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m. |
|
| Fosamax | Active Comparator | 70mg po every week for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99Tc-MDP | Drug | 99Tc-MDP, H20000218 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Bone Mineral Density in Lumbar and Hip | Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry | baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Turnover Markers | bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP) | baseline and 12 months |
| Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) |
Not provided
Inclusion Criteria:
(1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chao Ma, MD | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuclear Medicine Xinhua Hospital | Shanghai | Shanghai Municipality | 200092 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
In the total of 142 included patients, 70 were treated with 99Tc-MDP and 72 were treated with Fosamax.
Patients were enrolled in three centers (Tenth People's Hospital of Tongji University, Shanghai No. 4 People's Hospital and Xinhua Hospital School of Medicine Shanghai Jiaotong University) from January 2015 to December 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 99Tc-MDP | 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m. 99Tc-MDP: 99Tc-MDP, H20000218 |
| FG001 | Fosamax | 70mg po every week for 12 months. Alendronate Sodium: H20080172 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 99Tc-MDP | 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m. 99Tc-MDP: 99Tc-MDP, H20000218 |
| BG001 | Fosamax |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change of Bone Mineral Density in Lumbar and Hip | Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry | Posted | Mean | Standard Deviation | percentage change | baseline, 6 months, and 12 months |
|
Adverse event data were collected at 1year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 99Tc-MDP | 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m. 99Tc-MDP: 99Tc-MDP, H20000218 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper gastrointestinal (GI) adverse events | Gastrointestinal disorders | Systematic Assessment | In the 6/72 patients with GI adverse events treated with alendronate, 2 cases had abdominal pain, 4 had dyspepsia. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chao Ma | Tenth People's Hospital of Tongji University | 02125078593 | 86 | mc_7419@hotmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2021 | Apr 22, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013667 | Technetium |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
Not provided
Not provided
Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.
Not provided
Not provided
Not provided
Not provided
| Fosamax | Drug | H20080172 |
|
|
The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome. The questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome. |
| baseline, 6 months, and 12 months |
| Side Effects | A transient rash and phlebitis, gastrointestinal reaction. | 6 months, and 12 months |
70mg po every week for 12 months.
Alendronate Sodium: H20080172
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TNM staging | T1N0-1, indicated participants had tumor ≤2 cm in greatest dimension, and with (N1) or without (N0)metastasis to lymph node; T2N0-1, tumor size >2 cm but ≤4 cm in greatest dimension, and with or without metastasis to lymph node; T3N0-1, tumor size >4 cm, and with or without metastasis to lymph node; TxNX, indicated participants had unknown tumor size and unknown metastasis to lymph node; TxN0-1, indicated participants had unknown tumor size, and with or without metastasis to lymph node; T1-2Nx, tumor ≤2 cm(T1) or >2 cm but ≤4 cm (T2), and unknown metastasis to lymph node. | Number | number of participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Bone Turnover Markers | bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP) | Posted | Mean | Standard Deviation | ng/ml | baseline and 12 months |
|
|
|
| Secondary | Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) | The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome. The questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome. | Posted | Mean | Full Range | scores on a scale | baseline, 6 months, and 12 months |
|
|
|
| Secondary | Side Effects | A transient rash and phlebitis, gastrointestinal reaction. | Posted | Number | side effects | 6 months, and 12 months |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Fosamax | 70mg po every week for 12 months. Alendronate Sodium: H20080172 | 0 | 72 | 0 | 72 | 6 | 72 |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D028561 |
| Transition Elements |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| CTX before treatment |
|
| CTX at 12months |
|
| Physical component summary at 12months by 36-item Short Form Health Status Survey questionnaire |
|
| Mental component score at baseline by 36-item Short Form Health Status Survey questionnaire |
|
| Mental component score at 6months by 36-item Short Form Health Status Survey questionnaire |
|
| Mental component score at 12months by 36-item Short Form Health Status Survey questionnaire (0-100) |
|