Trial Outcomes & Findings for Stem Cell Recruitment in Osteoporosis Therapy (NCT NCT01656629)

NCT ID: NCT01656629

Last Updated: 2020-08-21

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: up to 3 months
• Results posted on: 2020-08-21

Participant Flow

Participant milestones

Measure	Teriparatide teriparatide 20 mcg sq for 3 months Teriparatide: 20 mcg subq daily for 3 months	Alendronate 70 mg po weekly for 3 months Alendronate: 70 mg weekly for 3 months	Calcium and Vitamin D calcium 630 mg vitamin D 500 units daily for 3 months calcium and vitamin D
Overall Study STARTED	21	18	16
Overall Study COMPLETED	16	16	14
Overall Study NOT COMPLETED	5	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stem Cell Recruitment in Osteoporosis Therapy

Baseline characteristics by cohort

Measure	Teriparatide n=21 Participants teriparatide 20 mcg sq for 3 months Teriparatide: 20 mcg subq daily for 3 months	Alendronate n=18 Participants 70 mg po weekly for 3 months Alendronate: 70 mg weekly for 3 months	Calcium and Vitamin D n=16 Participants calcium 630 mg vitamin D 500 units daily for 3 months calcium and vitamin D	Total n=55 Participants Total of all reporting groups
Age, Customized 18 - 49 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 50 - 80 years	21 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	55 Participants n=4 Participants
Age, Customized 81 - 100 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	18 participants n=7 Participants	16 participants n=5 Participants	55 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 3 months

Outcome measures

Measure	Teriparatide n=16 Participants teriparatide 20 mcg sq for 3 months Teriparatide: 20 mcg subq daily for 3 months	Alendronate n=16 Participants 70 mg po weekly for 3 months Alendronate: 70 mg weekly for 3 months	Calcium and Vitamin D n=14 Participants calcium 630 mg vitamin D 500 units daily for 3 months calcium and vitamin D
The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).	0.0000242 percent change in osteoprogenitor cells Standard Deviation 0.0000283	0.0000104 percent change in osteoprogenitor cells Standard Deviation 0.0000231	-0.0000068 percent change in osteoprogenitor cells Standard Deviation 0.0000449

SECONDARY outcome

Timeframe: 3 months

Population: Collected bone biopsy samples were not analyzed and no data was generated. Therefore data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Collected osteoblast assay samples were not analyzed and no data was generated. Therefore data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Teriparatide

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Alendronate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calcium and Vitamin D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Teriparatide n=21 participants at risk teriparatide 20 mcg sq for 3 months Teriparatide: 20 mcg subq daily for 3 months	Alendronate n=18 participants at risk 70 mg po weekly for 3 months Alendronate: 70 mg weekly for 3 months	Calcium and Vitamin D n=16 participants at risk calcium 630 mg vitamin D 500 units daily for 3 months calcium and vitamin D
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • Each participant was followed for 14 weeks for adverse events	0.00% 0/18 • Each participant was followed for 14 weeks for adverse events	0.00% 0/16 • Each participant was followed for 14 weeks for adverse events
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1 • Each participant was followed for 14 weeks for adverse events	0.00% 0/18 • Each participant was followed for 14 weeks for adverse events	0.00% 0/16 • Each participant was followed for 14 weeks for adverse events
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/21 • Each participant was followed for 14 weeks for adverse events	0.00% 0/18 • Each participant was followed for 14 weeks for adverse events	6.2% 1/16 • Number of events 1 • Each participant was followed for 14 weeks for adverse events

Additional Information

Dr. Suzanne Jan De Beur

Johns Hopkins University

Phone: 410-550-0100

Email: sjandebe@jhmi.edu

Results disclosure agreements

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