Trial Outcomes & Findings for A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism (NCT NCT01402115)

NCT ID: NCT01402115

Last Updated: 2012-10-12

Results Overview

DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12weeks

Results posted on

2012-10-12

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

The criteria were an age from 40 to 70 years, They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).

Participant milestones

Participant milestones
Measure	Polycan Polycan 150mg for 12 weeks	Placebo Placebo 15mg for 12 weeks
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polycan n=30 Participants Polycan 150mg for 12 weeks	Placebo n=30 Participants Placebo 15mg for 12 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	52.8 years STANDARD_DEVIATION 6.3 • n=5 Participants	52.9 years STANDARD_DEVIATION 5.8 • n=7 Participants	52.8 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12weeks

Population: per protocol analysis

DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Polycan n=29 Participants Polycan 150mg for 12 weeks	Placebo n=29 Participants Placebo 15mg for 12 weeks
Changes in DPD(Deoxypyridinoline) Pre	7.1 nanoMolar DPD per milliMolar creatine Standard Deviation 2.2	6.4 nanoMolar DPD per milliMolar creatine Standard Deviation 1.7
Changes in DPD(Deoxypyridinoline) Post	6.2 nanoMolar DPD per milliMolar creatine Standard Deviation 2.1	5.6 nanoMolar DPD per milliMolar creatine Standard Deviation 1.5

PRIMARY outcome

Timeframe: 12weeks

Population: per protocol analysis

OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Polycan n=29 Participants Polycan 150mg for 12 weeks	Placebo n=29 Participants Placebo 15mg for 12 weeks
Changes in OSC(Osteocalcin) Pre	16.1 ng/mL Standard Deviation 6.8	14.2 ng/mL Standard Deviation 5.2
Changes in OSC(Osteocalcin) Post	19.8 ng/mL Standard Deviation 7.7	17.0 ng/mL Standard Deviation 6.8

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Polycan n=29 Participants Polycan 150mg for 12 weeks	Placebo n=29 Participants Placebo 15mg for 12 weeks
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) Pre	344 µg/L Standard Deviation 183	314 µg/L Standard Deviation 217
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) Post	341 µg/L Standard Deviation 171	301 µg/L Standard Deviation 157

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Polycan n=29 Participants Polycan 150mg for 12 weeks	Placebo n=29 Participants Placebo 15mg for 12 weeks
Changes in bALP(Bone-specific Alkaline Phosphatase) Post	31.8 U/L Standard Deviation 11.7	29.8 U/L Standard Deviation 9.5
Changes in bALP(Bone-specific Alkaline Phosphatase) Pre	31.8 U/L Standard Deviation 11.3	28.6 U/L Standard Deviation 9.7

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Polycan n=29 Participants Polycan 150mg for 12 weeks	Placebo n=29 Participants Placebo 15mg for 12 weeks
Changes in PTH(Parathyroid Hormone) Pre	32.8 pg/mL Standard Deviation 10.4	31.1 pg/mL Standard Deviation 8.7
Changes in PTH(Parathyroid Hormone) Post	35.0 pg/mL Standard Deviation 9.3	33.6 pg/mL Standard Deviation 7.5

Adverse Events

Polycan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dal-Sik Kim, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place