Muscle Wasting (Atrophy) After Hip Fracture Surgery Clinical Trial
Official title:
A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture
| Verified date | August 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.
| Status | Completed |
| Enrollment | 251 |
| Est. completion date | October 25, 2018 |
| Est. primary completion date | May 14, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: Must have X-ray confirmed successful hip fracture repair; Must have completed surgical wound healing; Ability to walk a specified distance with or without a walking aid; Must weigh at least 35 kg. Exclusion Criteria: Must not have history of any other lower limb fractures in the past 6 months; Must not have certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at least 3 months in the past year; |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novartis Investigative Site | Ciudad Autonoma de Bs As | |
| Australia | Novartis Investigative Site | Bedford Park | South Australia |
| Austria | Novartis Investigative Site | Graz | |
| Belgium | Novartis Investigative Site | Brugge | |
| Belgium | Novartis Investigative Site | Genk | |
| Belgium | Novartis Investigative Site | Gent | |
| Chile | Novartis Investigative Site | Santiago | |
| Colombia | Novartis Investigative Site | Barranquilla | |
| Colombia | Novartis Investigative Site | Cali | Valle Del Cauca |
| Czechia | Novartis Investigative Site | Brno | Czech Republic |
| Czechia | Novartis Investigative Site | Hradec Kralove | Czech Republic |
| Czechia | Novartis Investigative Site | Pardubice | Czech Republic |
| Czechia | Novartis Investigative Site | Plzen | Czech Republic |
| Czechia | Novartis Investigative Site | Praha 10 | |
| Czechia | Novartis Investigative Site | Praha 5 | Czech Republic |
| France | Novartis Investigative Site | Lille Cedex | |
| France | Novartis Investigative Site | Montpellier | |
| Germany | Novartis Investigative Site | Bad Abbach | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Magdeburg | |
| Germany | Novartis Investigative Site | Würzburg | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Hatvan | |
| Japan | Novartis Investigative Site | Kamakura-city | Kanagawa |
| Japan | Novartis Investigative Site | Kochi-city | Kochi |
| Japan | Novartis Investigative Site | Kumamoto-city | Kumamoto |
| Japan | Novartis Investigative Site | Nishinomiya-city | Hyogo |
| Japan | Novartis Investigative Site | Okayama city | Okayama |
| Japan | Novartis Investigative Site | Toyama-City | Toyama |
| Mexico | Novartis Investigative Site | Aguascalientes | |
| Mexico | Novartis Investigative Site | San Luis Potosi | |
| Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
| Russian Federation | Novartis Investigative Site | Sestroretsk | |
| Russian Federation | Novartis Investigative Site | St.- Petersburg | |
| Russian Federation | Novartis Investigative Site | Yaroslavl | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Switzerland | Novartis Investigative Site | Genève 14 | |
| Taiwan | Novartis Investigative Site | Kaohsiung | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taoyuan | |
| Turkey | Novartis Investigative Site | Istanbul | |
| Turkey | Novartis Investigative Site | Izmir | |
| United Kingdom | Novartis Investigative Site | Bath | |
| United States | Novartis Investigative Site | Denver | Colorado |
| United States | Novartis Investigative Site | El Cajon | California |
| United States | Novartis Investigative Site | Gainesville | Georgia |
| United States | Novartis Investigative Site | New York | New York |
| United States | Novartis Investigative Site | Phoenix | Arizona |
| United States | Novartis Investigative Site | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Argentina, Australia, Austria, Belgium, Chile, Colombia, Czechia, France, Germany, Hungary, Japan, Mexico, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 | Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed | baseline, weeks 12 and 24 | |
| Secondary | Change From Baseline in Gait Speed at Week 24 (Meters/Sec) | Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg was added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed |
Baseline, Week 24 | |
| Secondary | Change From Baseline in Short Physical Performance Battery at Weeks 24 | MMRM change from baseline in total score by treatment & visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab & facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group & it was used only for dose response modelling & not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed | Week 24 | |
| Secondary | Incidence of Falls up to Week 48 | Group falls rate The frequency of having at least one fall up to Week 48 was summarized by treatment groups Incidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself |
Up to Week 48 |