When it's time to rebuild bone, it's time for TYMLOS.1
TYMLOS rebuilds a foundation of new bone and provides clinically meaningful fracture risk reduction.1
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TYMLOS efficacy was demonstrated in the ACTIVE trial.1,2
Study design: A randomized, multicenter, double-blind, placebo- and active-controlled clinical study in postmenopausal women with osteoporosis (N=2,463) aged 49 to 86 years (mean age 69 years) who were randomized to receive TYMLOS 80 mcg (n=824), placebo (n=821), or teriparatide 20 mcg (n=818) subcutaneously once daily for 18 months to assess efficacy and safety of abaloparatide injection.1,2
Primary endpoint: Incidence of new vertebral fracture at 18 months (TYMLOS vs placebo).*1
Secondary endpoints:
- Incidence of nonvertebral fractures at 18 months (TYMLOS vs placebo and TYMLOS vs teriparatide)†1,2
- BMD change from baseline at the lumbar spine, total hip, and femoral neck at 18 months (TYMLOS vs placebo; comparisons at 6 and 12 months are exploratory)‡1,2
- BMD change from baseline at the lumbar spine, total hip, and femoral neck, comparing teriparatide and TYMLOS at 6 months (comparisons at 12 and 18 months are exploratory)‡2
This study was not designed to provide head-to-head comparative efficacy data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.
*Modified ITT population, which includes patients who had both pretreatment and posttreatment spine radiographs.1
†Nonvertebral fractures were measured using the ITT population and excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.1
‡Results reported in the ITT population, which included patients randomized in the efficacy study; last observation carried forward.1,2
BMD=bone mineral density; ITT=intent-to-treat.
TYMLOS helps protect patients against fracture while on treatment.1
§Modified ITT population, which includes patients who had both pretreatment and posttreatment spine radiographs.
¶95% CI: 61, 95.
#95% CI: 2.1, 5.4.
BMD changes from baseline over time for TYMLOS, teriparatide, and placebo groups1–3
TYMLOS has a well-established safety profile.1,2,4,5
| MOST COMMON ADVERSE REACTIONS‡‡‡1,2 | TYMLOS (n=822) | PLACEBO (n=820) |
|---|---|---|
| Hypercalciuria | 11% | 9% |
| Dizziness | 10% | 6% |
| Nausea | 8% | 3% |
| Headache | 8% | 6% |
| Palpitations | 5% | 0.4% |
| Fatigue | 3% | 2% |
| Abdominal pain, upper | 3% | 2% |
| Vertigo | 2% | 2% |
| Hypercalcemia§§§ | 3% | 0.1% |
†††The safety analysis included an open-label, active comparative arm with teriparatide (n=818). This study was not designed to provide head-to-head comparative safety data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2
‡‡‡Adverse reactions reported in ≥2% of TYMLOS-treated patients.1
§§§Hypercalcemia was a prespecified safety endpoint, defined as albumin-corrected serum calcium of at least 10.7 mg/dL (2.67 mmol/L) at any time point.1,2
ACTIVE trial participants
included patients with1,6:
Type 2
Diabetes
Varying Degrees of
Renal Impairment
Varying Degrees of
Cardiovascular Risk
Efficacy was maintained with follow-on therapy in the ACTIVExtend trial.1,4,5
The extension study evaluated if the fracture risk reductions and increases in BMD achieved with TYMLOS could be maintained with follow-on therapy with alendronate.1,4,5
Extension study design: A 24-month, open-label, follow-up study of postmenopausal women who completed the 18-month ACTIVE trial and enrolled in the extension study where they transitioned to alendronate 70 mg weekly as follow-on maintenance therapy from either TYMLOS 80 mcg (n=558) or placebo (n=581).1
Primary endpoint: Percent of patients with ≥1 new vertebral fracture from ACTIVE trial baseline through 6 months of alendronate treatment (Month 25).¶¶¶1
Secondary endpoints:
- Percent of patients with ≥1 new nonvertebral fracture from ACTIVE trial baseline through 6 months of alendronate treatment (Month 25)###1,4
- Mean percentage change in BMD at lumbar spine, total hip, and femoral neck from ACTIVE trial baseline through Month 25###1,4
Exploratory endpoints:
- Percent of patients with ≥1 new vertebral¶¶¶ and nonvertebral fracture at the end of the ACTIVExtend trial (Month 43)###
- Mean percentage change in BMD at lumbar spine, total hip, and femoral neck from ACTIVE trial baseline through Month 43###5
¶¶¶Results reported in the modified ITT population, which included patients who had both pretreatment and posttreatment spine radiographs.1
###Results reported in the ITT population, which included patients randomized in the efficacy study. Nonvertebral fractures excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.1,4,5
BMD=bone mineral density; ITT=intent-to-treat.
TYMLOS fracture risk reduction was preserved with follow-on therapy.1,4,5
By alendronate antiresorptive therapy1,3,5
Patients significantly increased BMD with TYMLOS and maintained it after transitioning to alendronate antiresorptive therapy.1,4,5
In a 25-month analysis of the secondary endpoint,***** significant increases in BMD achieved with TYMLOS at 18 months were maintained after transitioning to 6 months of follow-on therapy with alendronate (TYMLOS vs placebo; P<0.001 at all sites)1,4:
- Lumbar spine—12.8% vs 3.5%; treatment difference: 9.3%
- Total hip—5.5% vs 1.4%; treatment difference: 4.1%
- Femoral neck—4.5% vs 0.5%; treatment difference: 4.1%
ALN=alendronate; ARR=absolute risk reduction; BMD=bone mineral density; CI=confidence interval; ITT=intent-to-treat; SAEs=serious adverse events.
The ATOM trial evaluated the efficacy and safety of TYMLOS in men.1,7
Study design: A Phase 3 randomized, double-blind, placebo-controlled study in men with osteoporosis (N=228) aged 42 to 85 years who were randomized to receive TYMLOS 80 mcg (n=149) or placebo (n=79) subcutaneously once daily for 12 months to assess efficacy and safety of abaloparatide injection.1
Primary endpoint: Change in lumbar spine BMD at 12 months compared with placebo.1
Secondary endpoints:
- Percent change from baseline in total hip and femoral neck BMD at 12 months1,7
- Percent change from baseline in BMD at 3 and 6 months for lumbar spine, total hip, and femoral neck7
TYMLOS is proven to significantly increase BMD in men with osteoporosis.1,7
| 3 MONTHS (all P<0.01) | Lumbar Spine | Total Hip | Femoral Neck |
|---|---|---|---|
| PLACEBO (N=79) | 1.1% | 0.2% | 0.2% |
| TYMLOS (N=149) | 3.8% | 1.1% | 1.4% |
| 6 MONTHS (all P<0.0001) | Lumbar Spine | Total Hip | Femoral Neck |
| PLACEBO (N=79) | 0.6% | <0.1% | –0.2% |
| TYMLOS (N=149) | 5.5% | 1.4% | 1.5% |
TYMLOS showed a consistent safety profile in the ATOM trial.1
| MOST COMMON ADVERSE REACTIONS#####1 | TYMLOS (n=149) | PLACEBO (n=79) |
|---|---|---|
| Injection site erythema | 13% | 5% |
| Dizziness | 9% | 1% |
| Arthralgia | 7% | 1% |
| Injection site swelling | 7% | 0% |
| Injection site pain | 6% | 0% |
| Contusion | 3% | 0% |
| Abdominal distention | 3% | 0% |
| Diarrhea | 3% | 0% |
| Nausea | 3% | 0% |
| Abdominal pain | 2% | 0% |
| Bone pain | 2% | 0% |
| Hypercalcemia****** | 3% | 0% |
#####Adverse reactions reported in ≥2% of TYMLOS-treated patients.1
******Hypercalcemia was defined as albumin-corrected serum calcium of at least 10.8 mg/dL (2.67 mmol/L) at any time point.1
BMD=bone mineral density; CI=confidence interval.
TYMLOS rebuilds bone1
Change the trajectory of osteoporosis for your patients.
The TYMLOS Pen
TYMLOS is self-administered daily using an injection pen.
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