Trial Outcomes & Findings for 99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis (NCT NCT02304757)

NCT ID: NCT02304757

Last Updated: 2021-11-17

Results Overview

Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: baseline, 6 months, and 12 months
• Results posted on: 2021-11-17

Participant Flow

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.

In the total of 142 included patients, 70 were treated with 99Tc-MDP and 72 were treated with Fosamax.

Participant milestones

Measure	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	Fosamax 70mg po every week for 12 months. Alendronate Sodium: H20080172
Overall Study STARTED	70	72
Overall Study COMPLETED	70	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	99Tc-MDP n=70 Participants 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	Fosamax n=72 Participants 70mg po every week for 12 months. Alendronate Sodium: H20080172	Total n=142 Participants Total of all reporting groups
Age, Continuous	64.29 years STANDARD_DEVIATION 7.96 • n=70 Participants	62.73 years STANDARD_DEVIATION 7.24 • n=72 Participants	63 years STANDARD_DEVIATION 7 • n=142 Participants
Sex/Gender, Customized Sex: Female	70 participants n=70 Participants	72 participants n=72 Participants	142 participants n=142 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	70 participants n=70 Participants	72 participants n=72 Participants	142 participants n=142 Participants
TNM staging T1N0-1	35 number of participants n=70 Participants	39 number of participants n=72 Participants	74 number of participants n=142 Participants
TNM staging T2N0-1	6 number of participants n=70 Participants	5 number of participants n=72 Participants	11 number of participants n=142 Participants
TNM staging T3N0-1	4 number of participants n=70 Participants	9 number of participants n=72 Participants	13 number of participants n=142 Participants
TNM staging T4N0-1	18 number of participants n=70 Participants	12 number of participants n=72 Participants	30 number of participants n=142 Participants
TNM staging TxNx	1 number of participants n=70 Participants	1 number of participants n=72 Participants	2 number of participants n=142 Participants
TNM staging TxN0-1	5 number of participants n=70 Participants	4 number of participants n=72 Participants	9 number of participants n=142 Participants
TNM staging T1-2Nx	1 number of participants n=70 Participants	2 number of participants n=72 Participants	3 number of participants n=142 Participants

PRIMARY outcome

Timeframe: baseline, 6 months, and 12 months

Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry

Outcome measures

Measure	99Tc-MDP n=70 Participants 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	Fosamax n=72 Participants 70mg po every week for 12 months. Alendronate Sodium: H20080172
Percent Change of Bone Mineral Density in Lumbar and Hip Percentage change of total hip at month 6	0.9 percentage change Standard Deviation 7.7	4.9 percentage change Standard Deviation 7.7
Percent Change of Bone Mineral Density in Lumbar and Hip Percentage change of lumbar spine at month 6	3.0 percentage change Standard Deviation 6.6	3.2 percentage change Standard Deviation 7.1
Percent Change of Bone Mineral Density in Lumbar and Hip Percentage change of lumbar spine month 12	3.8 percentage change Standard Deviation 10.9	5.1 percentage change Standard Deviation 6.1
Percent Change of Bone Mineral Density in Lumbar and Hip Percentage change of total hip at month 12	5.1 percentage change Standard Deviation 17	4.6 percentage change Standard Deviation 9.6

SECONDARY outcome

Timeframe: baseline and 12 months

bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)

Outcome measures

Measure	99Tc-MDP n=70 Participants 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	Fosamax n=72 Participants 70mg po every week for 12 months. Alendronate Sodium: H20080172
Bone Turnover Markers PINP before treatment	43.7725 ng/ml Standard Deviation 14.74802	29.255 ng/ml Standard Deviation 29.46603
Bone Turnover Markers PINP at 12months	52.6422 ng/ml Standard Deviation 20.56123	20.56123 ng/ml Standard Deviation 25.34437
Bone Turnover Markers CTX before treatment	0.4657 ng/ml Standard Deviation 0.25277	0.1526 ng/ml Standard Deviation 0.14138
Bone Turnover Markers CTX at 12months	0.3707 ng/ml Standard Deviation 0.21062	0.1771 ng/ml Standard Deviation 0.16019

SECONDARY outcome

Timeframe: baseline, 6 months, and 12 months

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.

Outcome measures

Measure	99Tc-MDP n=70 Participants 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	Fosamax n=72 Participants 70mg po every week for 12 months. Alendronate Sodium: H20080172
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Physical component summary at baseline by 36-item Short Form Health Status Survey questionnaire	61.4 scores on a scale Interval 17.5 to 92.5	64.4 scores on a scale Interval 30.5 to 87.5
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Physical component summary at 6months by 36-item Short Form Health Status Survey questionnaire	67.587 scores on a scale Interval 14.0 to 100.0	69.09 scores on a scale Interval 25.5 to 94.25
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Physical component summary at 12months by 36-item Short Form Health Status Survey questionnaire	69 scores on a scale Interval 30.25 to 94.25	68 scores on a scale Interval 40.0 to 92.25
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Mental component score at baseline by 36-item Short Form Health Status Survey questionnaire	65.7 scores on a scale Interval 19.38 to 100.0	65.7 scores on a scale Interval 34.88 to 95.88
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Mental component score at 6months by 36-item Short Form Health Status Survey questionnaire	69.0359 scores on a scale Interval 14.0 to 100.0	66.24 scores on a scale Interval 39.38 to 95.0
Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100) Mental component score at 12months by 36-item Short Form Health Status Survey questionnaire (0-100)	69.2645 scores on a scale Interval 15.0 to 100.0	67.087 scores on a scale Interval 37.75 to 92.25

SECONDARY outcome

Timeframe: 6 months, and 12 months

A transient rash and phlebitis, gastrointestinal reaction.

Outcome measures

Measure	99Tc-MDP n=70 Participants 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	Fosamax n=72 Participants 70mg po every week for 12 months. Alendronate Sodium: H20080172
Side Effects abdominal pain	0 side effects	2 side effects
Side Effects dyspepsia	0 side effects	4 side effects

Adverse Events

99Tc-MDP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fosamax

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	99Tc-MDP n=70 participants at risk 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	Fosamax n=72 participants at risk 70mg po every week for 12 months. Alendronate Sodium: H20080172
Gastrointestinal disorders upper gastrointestinal (GI) adverse events	0.00% 0/70 • Adverse event data were collected at 1year.	8.3% 6/72 • Number of events 72 • Adverse event data were collected at 1year.

Additional Information

Chao Ma

Tenth People's Hospital of Tongji University

Phone: 02125078593

Email: mc_7419@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place