Trial Outcomes & Findings for Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women (NCT NCT00361595)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2017-04-21

Participant Flow

Enrollment, 35 Subjects Start date: August, 2006 Completion date: April, 2008 Study took place at an academic medical center, recruiting subjects from investigator's practice.

Participant milestones

Participant milestones
Measure	Open Label 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=35 Participants 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants
Age, Continuous	68.8 years STANDARD_DEVIATION 11.2 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	35 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Outcome measures

Outcome measures
Measure	Open Label n=35 Participants 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)	2.2 grams/cm^2 Standard Deviation .036

SECONDARY outcome

Timeframe: 6 months and 12 months

Change in bone density (grams/cm\^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.

Outcome measures

Outcome measures
Measure	Open Label n=35 Participants 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months	2.4 grams/cm^2 Standard Deviation .031

SECONDARY outcome

Timeframe: 12 months

Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.

Outcome measures

Outcome measures
Measure	Open Label n=35 Participants 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)	-49.1 ng/ml Standard Deviation 37.6

SECONDARY outcome

Timeframe: 12 months

Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.

Outcome measures

Outcome measures
Measure	Open Label n=35 Participants 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)	-66.2 mcg/ml Standard Deviation 29.1

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label n=35 participants at risk 5 mg zoledronic acid in a single 15 minute IV (intervenous)
Blood and lymphatic system disorders Transient increase in serum creatinine	5.7% 2/35 • Number of events 2
General disorders Flu-like symptoms	17.1% 6/35 • Number of events 6

Additional Information

Chad Deal

Cleveland Clinic

Phone: 216-444-6575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place