Postmenopausal Osteoporosis (PMO)Phase 2NCT01992159

Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

A Phase 2 study testing Romosozumab in people with Postmenopausal Osteoporosis (PMO), run by Amgen at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis. Read more about this study

Who is it for?: Ages 55 to 85 years, women only
Conditions the study is for: Postmenopausal Osteoporosis (PMO)
What is being tested?: Romosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: 27 sitesJapan
Study dates: 12 Oct 2012to 17 Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Who cannot join

Severe osteoporosis
Use of agents affecting bone metabolism
History of metabolic or bone disease (except osteoporosis)
Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
Current, uncontrolled hyper- or hypoparathyroidism

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Japan27 sites

Research Site
Anjyo-shi, Aichi-ken, 446-0063
Research Site
Fukuoka, Fukuoka, 814-0165
Research Site
Hachioji-shi, Tokyo, 192-0046
Research Site
Kita-adachi-gun, Saitama, 362-0806
Research Site
Kitakyushu-shi, Fukuoka, 800-0057
Research Site
Kiyose-shi, Tokyo, 204-0021
Research Site
Kyoto, Kyoto, 602-8026
Research Site
Matsumoto-shi, Nagano, 390-1401
Research Site
Minato-ku, Tokyo, 108-0075
Research Site
Mizunami-shi, Gifu, 509-6134
Research Site
Morioka, Iwate, 020-0066
Research Site
Osaka, Osaka, 559-0011
Research Site
Ōta-ku, Tokyo, 146-0094
Research Site
Saito-shi, Miyazaki, 881-0113
Research Site
Sapporo, Hokkaido, 063-0814
Research Site
Sapporo, Hokkaido, 065-0024
Research Site
Sendai, Miyagi, 981-3132
Research Site
Sendai, Miyagi, 983-0862
Research Site
Shinagawa-ku, Tokyo, 140-0011
Research Site
Suginami-ku, Tokyo, 166-0003
Research Site
Takatsuki-shi, Osaka, 569-1123
Research Site
Toshima-ku, Tokyo, 171-0033
Research Site
Ueda-shi, Nagano, 386-0151
Research Site
Ueda-shi, Nagano, 386-0405
Research Site
Yanagawa-shi, Fukuoka, 832-0059
Research Site
Yokohama, Kanagawa, 223-0062
Research Site
Yokohama, Kanagawa, 231-0861

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Conditions: Postmenopausal Osteoporosis (PMO)
Being tested: Romosozumab, Placebo
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Medical subject headings: Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RomosozumabDrug
Also called AMG 785, EVENITY™
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection

Study groups in NCT01992159
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months. Receives: Drug: Placebo
Romosozumab 70 mg	Experimental	Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months. Receives: Drug: Romosozumab
Romosozumab 140 mg	Experimental	Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months. Receives: Drug: Romosozumab
Romosozumab 210 mg	Experimental	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. Receives: Drug: Romosozumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 12 months

Secondary outcomes (10)

Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 6 months
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 12 months
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Measured: Baseline and 12 months
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Measured: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Measured: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Osteocalcin
Measured: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Measured: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Area Under the Curve Through Month 12 of P1NP
Measured: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 201217 Jun 2015

First posted25 Nov 2013 (estimated)
Study start12 Oct 2012
Primary completion9 Oct 2014
Study completion17 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Postmenopausal Osteoporosis (PMO)Studies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992159
Sponsor's protocol ID: 20101291
Status last verified: Mar 2019
First submitted: 19 Nov 2013
Last updated: 25 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.
PubMed 28687496

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
ClinicalTrials.gov ID: NCT01992159
Acronym / sponsor ID: 20101291
Conditions: Postmenopausal Osteoporosis (PMO)
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 12 Oct 2012 (actual)
Primary completion: 9 Oct 2014 (actual)
Study completion: 17 Jun 2015 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 25 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 70 mg	Experimental	Drug: RomosozumabParticipants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 140 mg	Experimental	Drug: RomosozumabParticipants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 210 mg	Experimental	Drug: RomosozumabParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Who may qualify

Ages: 55 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Key exclusion criteria (7 listed)

Severe osteoporosis
Use of agents affecting bone metabolism
History of metabolic or bone disease (except osteoporosis)
Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
Current hyper- or hypocalcemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RomosozumabAlso: AMG 785, EVENITY™Administered by subcutaneous injection	Drug	Romosozumab 140 mg, Romosozumab 210 mg, Romosozumab 70 mg
PlaceboAdministered by subcutaneous injection	Drug	Placebo

Primary outcome

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Time frame: Baseline and 12 months
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

10 secondary outcomes

Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
Time frame: Baseline and 6 months
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
Time frame: Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
Time frame: Baseline and 12 months
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
Time frame: Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
Time frame: Baseline and 12 months
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Osteocalcin
Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Area Under the Curve Through Month 12 of P1NP
Time frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

Results and safety

Results posted to the registry on 25 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	63	59
Romosozumab 70 mg	63	55
Romosozumab 140 mg	63	62
Romosozumab 210 mg	63	59

Primary outcome: Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine

Time frame: Baseline and 12 months. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	Placebo n = 59	Romosozumab 70 mg n = 55	Romosozumab 140 mg n = 62	Romosozumab 210 mg n = 59
Value	0.9 (0.1 to 1.8)	8.4 (7.6 to 9.3)	13.3 (12.1 to 14.5)	16.9 (15.5 to 18.4)

Placebo vs Romosozumab 70 mg: Treatment Difference: 7.5, p < 0.0001, Repeated Measures Model
Placebo vs Romosozumab 140 mg: Treatment Difference: 12.4, p < 0.0001, Repeated Measures Model
Placebo vs Romosozumab 210 mg: Treatment Difference: 16.0, p < 0.0001, Repeated Measures Model

Population analysed: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement (primary efficacy subset).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 63 (7.9%)	20 of 63 (31.7%)	Not reported
Romosozumab 70 mg	6 of 63 (9.5%)	33 of 63 (52.4%)	Not reported
Romosozumab 140 mg	3 of 63 (4.8%)	29 of 63 (46%)	Not reported
Romosozumab 210 mg	2 of 63 (3.2%)	32 of 63 (50.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28687496Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Romosozumab in people with Postmenopausal Osteoporosis (PMO), run by Amgen at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992159, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.